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Formative Usability Testing Webinar & Template Bundle

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In this formative usability testing webinar, you will learn how and why to perform formative usability testing.

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Formative Usability Testing Webinar ($79)

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Formative Usability Testing Webinar & Template
This webinar reviews Medical Device Academy's Formative Usability Template in detail. The webinar also explains the three reasons for conducting formative usability testing. The webinar and template comply with IEC 62366-1 and applicable FDA requirements.
Price: $79.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After verifying the transaction, please check your email for the download (including your spam folder). 

Who should watch this Formative Usability webinar and why?

This webinar was recorded on Monday, March 11, 2024, for the design and development teams of medical device manufacturers. You can purchase it on-demand and watch the training as often as you wish. You should include it in your onboarding plan for all new design team members. Most people think that formative usability testing is not important because there are no specific format or content requirements, and you are not required to submit it to the FDA. However, formative testing is an integral part of risk control option analysis to prevent use errors. As you design and develop different user interfaces, you need to test and retest the new versions for potential use errors. Identifying potential use errors is the most important purpose of doing formative testing. There are two other reasons why most people do formative usability testing:

  1. to help them develop better instructions for use
  2. to help them develop training materials

Below is a hilarious video that will demonstrate why formative testing is so important when you are writing instructions for use.

What you will receive

  • A Formative Usability Testing Protocol Template
  • Access to download the recording of the webinar from our Dropbox folder
  • Native slide deck for this webinar
  • FDA Guidance on Human Factors

There are 24 slides in the presentation slide deck, and the presentation is 62 minutes in duration. All content deliveries will be sent via AWeber emails to confirmed subscribers. Below are the top ten frequently asked questions that we receive about formative usability testing. These frequently asked questions and the answers provided are examples of the information you will learn in our formative usability testing webinar.

What is the difference between formative and summative usability testing?

“Formative” tests are any usability tests you perform during development. At the same time, “summative” testing is the final usability testing you perform to validate that your chosen user interface is effective. Many design teams perform formative testing of one kind or another without even realizing that is what they are doing. Unfortunately, design teams often forget to document the testing they performed during prototyping and product development. Formative usability testing probably always existed as part of product development, but not everyone recognizes the term and identifies their work as “formative.” The most important reason for documenting formative usability testing is to identify which user interface designs failed and why so that future design teams can learn from your failures.

Why don’t more companies do usability testing?

Everyone likes to believe they can skip steps in the learning process, but some lessons can only be learned the hard way. When a medical device design team is developing a user interface for a new product, they need to learn which designs will fail and why before they can fully understand how to design the best user interface for the device. Therefore, most design and development teams will select a user interface they are familiar with or see used by a competitor product. The team will not always test the proposed design solution because they have no reason to believe the chosen interface will fail. Unfortunately, this can lead to failure later in the design process. Then the team will need to backtrack and repeat the evaluation of various interface designs.

What is the best approach?

“Fail small and fail fast” is the best advice for anyone performing formative usability testing. Instead of writing a lengthy protocol and recruiting ten subjects to evaluate your proposed user interface, you might consider building a couple of different prototypes and asking two or three people which prototype they prefer and why. Another simple question is, “Tell me what you think of this design?” Iterative formative testing over time with different users is better than one testing session with many users. It is also better to start collecting formative usability testing data as early in development as possible. Gathering data earlier in the process will ensure that users direct the development of your device instead of the design team developing a new device in a direction that users do not prefer.

When should formative testing be planned during the design process?

Formative testing should be planned during the development phase of the design process. During this phase, medical device manufacturers evaluate multiple design solutions as risk controls for their devices. Use-related risks should be included in this, and the formative usability testing is intended to identify which user interface will do the best job of eliminating the use errors. It is important to evaluate these potential user interfaces and verify that there are no use errors that the design team overlooked during this design phase. This is also the phase of design when the instructions for use are developed and user training is developed. This formative usability testing should be completed before your design freeze and the verification and validation testing start.

What are the different types of formative testing?

Formative usability testing can be used as a pilot for your summative usability testing protocol before scheduling the final testing. However, there are many other types of formative testing. The most common reason for doing this testing is to identify potential use errors not originally identified in your user-related risk analysis (URRA). Another type of testing is to simulate the device’s use to ensure that every user task is identified in the instructions for use. Finally, design teams will conduct formative usability testing to develop training materials for training new users on properly using their medical device.

Which types of formative tests are the most useful?

Use-related risks are difficult to identify unless you conduct simulated use testing with your device. Therefore, you need to get your device in the hands of your intended users, in the intended use environment, and ask them to simulate the use of the device. It is not critical to evaluate a specific number of users. Two or three users might be enough, but simulated use by intended users in the intended use environment is essential to give you the information you need regarding potential use errors. It is also important to avoid “leading” the users. Instead of asking users to perform a specific task, ask users to show you how they would use the device. Ask them what they like about the device and what they don’t like about it. Ask users what they think about the device and how it compares to other devices they are already using.

Who should you recruit for your formative usability testing?

You should start your human factors process by defining the intended user of your device and by defining if there is more than one user group. You should recruit subjects within this user group(s). You can use employees or friends to help you with initial feedback about the usability of your device’s user interface. However, what seems intuitive to one person may be the opposite for others with different experiences. Even the sequence of steps where users perform the same tasks can impact usability. Therefore, be cautious about relying upon data collected only from subjects outside your intended user group. Most companies disregard this advice because they are unsure how to recruit their intended users. However, if your company has difficulty identifying intended users for testing, you will also have difficulty marketing and selling your device later. This struggle may be an indicator that you need to involve marketing and salespeople that can get your prototypes in the hands of the intended users.

How should you document formative studies?

When performing summative usability testing, you already know your use-related risks. You have a list of critical tasks you are trying to verify that users can perform without errors. Because these tasks are clearly defined, writing a protocol and designing data collection forms for study moderators to use is easier. In contrast, when conducting formative usability testing, you are trying to identify use errors that you are not already aware of. Therefore, writing a detailed protocol and designing a data collection form is much harder.

For this reason, it is critical to capture the data with video recordings. This is a safety measure to ensure that you will not miss valuable use errors or tasks you have not already identified. Using video to record data allows the moderator to focus on observation and interviewing users with open-ended questions. This will generate the most value for your design team during development.

Where is testing performed?

While the design team is developing the list of design inputs for your new device, the team must create a definition for the intended users and the intended use environment. The formative usability and summative testing should be conducted in the intended use environment or you will need to simulate that use environment. If you are struggling to figure out how to simulate the intended use environment, you should systematically identify the characteristics of the intended use environment. These characteristics include temperature, humidity, ambient noise, other equipment, the number of people present, and the dimensions of the space. If you have a room with temperature and humidity control, you can add ambient noise by recording the intended use environment. You can rent equipment or place objects of the same size in the space. You can also identify the workspace restrictions by taping the floor to establish boundaries for the simulation. Adding these characteristics to a simulated environment opens the possibilities for additional places that can be used for formative usability testing.

What will happen if you skip formative testing?

If you skip formative usability testing, you will increase the possibility of failing your summative usability testing. If this happens, then your summative testing becomes your formative usability testing. After you fail, you must revise your testing protocol and repeat the study. Another possibility is that you will fail to identify a potential use error. If the FDA identifies this use error, you must repeat your testing. If the use error is never identified, you may have complaints or medical device reporting of use errors. In extreme cases, this could result in serious injuries or death.

Other Usability Engineering / Human Factors Training

About Your Instructor

Screenshot from webinar 150x150 Formative Usability Testing Webinar & Template Bundle

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

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Known Use Errors Search Webinar

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In this webinar, you will learn how to perform searches of the FDA databases for known use errors.

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Known Use Errors Search Webinar ($129)

WPeStore Thumbnail Known Use Errors Search Webinar
Known Use Errors Search Webinar
In this webinar, you will learn how to perform searches of the FDA databases for known use errors. You will also learn how to fill in our template for documenting these known use errors. A work instruction explaining the step-by-step search process is also included in this bundle. This webinar training will be hosted live on our Streamyard platform.
Price: $129.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After verifying the transaction, please check your email for the download (including your spam folder). 

What You Will Learn in the Known Use Errors Search Webinar:

In this webinar, you will learn how to perform searches of the FDA databases for known use errors. You will also learn how to fill in our template for documenting these known use errors. A work instruction explaining the step-by-step search process is also included in this bundle. This webinar training will be hosted live on our Streamyard platform.

When is the Known Use Errors Search Webinar?

This webinar will be hosted live on Thursday, September 19, 2024 @ 10:30 a.m. ET. If you are unavailable for the live presentation, the session will be recorded an you can download the recording and watch the training as often as you wish.

Thumbnail for Known Use Errror Search Known Use Errors Search Webinar

What you will receive

A Recording of the live webinar as well as:

Known Use Errors Search Webinar what they will recieve Known Use Errors Search Webinar

Other Usability Engineering / Human Factors Training

About Your Instructor

Screenshot from webinar 150x150 Known Use Errors Search Webinar

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

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Instructor engagement is the secret to training effectiveness

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The author discusses his personal experience with quality and regulatory training and shares his secrets for better instructor engagement.

What is instructor engagement?

Instructor engagement is a term that describes actions taken by the instructor to involve their class, whether the training is on-line or in person. Instructor engagement includes six basic elements:

  1. Training content and format
  2. Verbal communication
  3. Non-verbal communication
  4. Training environment
  5. Audience
  6. Audience involvement

Any one of the above six elements can ruin a training class, but a great instructor can compensate for weaknesses in any one area by taking advantage of the other elements.

To be successful, you need to hook your audience in the first ten seconds

It is crucial to engage your audience in the first ten seconds. When the audience is live, if you don’t engage them immediately they will find something on their phone to distract them. If the audience is on-line, they will swipe to the next video in their feed. Toastmasters suggests beginning your presentation by using one of five methods for hooking your audience:

  1. Tell a story
  2. Make a bold statement
  3. Ask a question
  4. Get the audience to laugh
  5. Ask the audience to visualize something

toastmasters speech Instructor engagement is the secret to training effectiveness

Consequences of poor engagement

If an instructor does not engage students, the best case scenario is that the training will not be effective. In other words, the class will not learn the material being taught or they will retain the information for less than 24 hours. For the student, their time and money was wasted. For the instructor, they will feel exhausted at the end of the training and they will have trouble finding future training jobs.

Results of good instructor engagement

If a class is engaged in training they will learn the material, retain the information in their long-term memory, and the will recommend the instructor to other people that are interested in learning about the topic. For the student, their time and money was well spent. For the instructor, they will feel energized at the end of the training and students will come up to them at the end of the training asking for a business card and to discuss future training opportunities.

Where can you find an examples of good and bad instructor engagement?

When I first wrote a blog on this topic it was 2012 and there were very few blogs and almost no videos dedicated to quality systems or regulatory affairs. Twelve years later, almost nobody reads blogs and there are multiple competitors that publish new videos weekly. The primary channel for watching videos is YouTube, but YouTubers are simultaneously live-streaming on YouTube, LinkedIn, and Facebook.  These channels are the best place to find examples of good and bad instructor engagement. You will probably have a strong opinion about the quality of the speaker in the first ten seconds, but the algorithms that guide your surfing of these platforms will automatically steer your viewing to the best videos. These videos are not considered to be the best solely on content and format. The amount of audience engagement is the biggest driver. The algorithm recommends videos based upon the percentage of audience retention, the number of comments by viewers, and the number of people that share the link to your video.

Why doesn’t Dr. Shulman’s video rank higher in the algorithm?

The video I embedded in this post has only 554 views currently, but it has been posted on YouTube almost six years. Why doesn’t this video rank higher and get recommended by YouTube to more people? Because there is no involvement of the original audience or the current YouTube audience. Despite the talented speaker and the use of video with clear PPT slides, there are no comments on YouTube. The content and format is good, and the verbal communication is good. However, RAPS has Dr. Shulman standing behind a podium at the event so the non-verbal communication is not as strong as it could be. In addition, large conferences are typically one of the weakest environments for encouraging instructor engagement with the audience. The video could receive much higher rankings if the original audience was involved in the video as well. If the question and answer session were included, that might have helped. RAPS could also improve the video’s performance by adding more details to the description of the video. Finally, the performance of the video is impacted by the number of subscribers to the RAPS YouTube channel and the engagement of those subscribers. To demonstrate this, I will add a comment to the video. That should cause a small increase in engagement and viewers.

How can you improve your internal quality system training?

Anyone can read and understand a procedure, but this is the least effective method of training people. You could also have employees watch a training video, but quality assurance and regulatory affairs are among the most boring topics on planet earth. Most of the training out there is “Blah, blah, blah…” and “Death by PowerPoint.” Instructor engagement for that type of training is poor, and it could get you fired. Don’t read your slides, don’t turn your back on the audience (or they’ll attack), and PLEASE don’t ever ask someone to read the definition of nonconformity out loud to the rest of the group. Inspire and engage the class. You need to get your audience to pay attention, ask questions, and share their own thoughts out loud. For example, instead of using a PowerPoint, try displaying the actual procedure and ask an audience member to find each of the points you are teaching in the procedure. You could even teach them a cool search tool (i.e., CTRL + F) to find the content. You might even adding a symbol to the procedure to help them find those requirements.

Nine ways to improve your own instructor engagement

If you are hiring a consultant to help you with quality and regulatory training, then you certainly want to hire an expert. However, it is more important that the speaker is engaging. Knowing this fact, you could try improving your own presentation skills to achieve higher instructor engagement for a lot less money. I’m six-foot, six inches tall, and I have a loud booming voice. My mother has red hair, and she was an opera singer. I’ve got the voice to fill any auditorium and stage presence to match. But you don’t have to be big, tall, or loud to capture the attention of your audience. Here are my top nine ways to improve instructor engagement:

  1. Practice vocal variety
  2. Move, don’t stay stationary
  3. Ask the audience questions
  4. Use anecdotes, case studies, and stories
  5. Try using props
  6. Take breaks
  7. Plan a surprise
  8. Force feed the audience legal stimulants
  9. Give students homework

What is vocal variety, how does it impact instructor engagement?

Vocal variety is more than just the volume of the speaker. Vocal variety consists of pitch, tone, volume, and pace. Generally I speak too fast and my voice is very loud. Therefore, if I want to emphasize a point I can exercise two changes in my voice to immediately capture the attention of students: 1) speak softly, and 2) speak slowly. Another approach I have used, is to speak slowly and repeat myself, but the most dynamic way to get your audience’s attention is to stop speaking for a few seconds. Silence is powerful.

Many people struggle to understand how to vary their pitch, but they’re overthinking it. When we ask a question, we raise the pitch of our voice slightly at the end. This upward inflexion of our voice signals to listeners that we are asking a question. For example, if you repeat the last one to three words in the other person’s sentence, and you say this with an upward inflection, the listener will perceive that you are asking a question to better understand what they mean. This is much more effective than asking “what do you mean?” For example, if a student in the class says “Is it enough if we perform annual reviews?” As the instructor you can employ the technique of mirroring by asking, “Annual reviews?” This will encourage the other person to elaborate on what they meant by “annual reviews.” This technique ensures that you know what the student meant, and it gives you time to consider what they said before you respond. This is also a strategy recommended by expert negotiators.

Movement is attractive

Most of our brain power is dedicated to processing what we see–not what we hear. Therefore, listeners are more likely to notice when you move. You can jolt your audience awake simply by stepping out from behind a podium or changing your movement pattern (e.g., occasionally moving forward instead of pacing side to side). Movement also includes body language. You can modify your posture, stance, and position in front of the audience to communicate information non-verbally. You can use gestures to communicate non-verbally or you can use facial expressions. For example, if you frown and shrug your shoulders, what does that mean?

Questions are essential for instructor engagement

No matter how smooth and eloquent your voice is, nobody wants to hear only you speak. This is one of the reasons conferences have multiple speakers. However, during a single presentation you can get students to participate and present some of the information by asking them questions. There are a few techniques that help get the audience to speak more. Instead of asking a question to the group as a whole, try pointing to a specific person, ask them their name, and then ask them a question. Second, in order to “break the ice” at the end of your presentation, have some “seed questions” prepared. If you are conducting a webinar, seed questions can be read by you. In a live presentation, you can give a list of seed questions to your host or friends in the audience. Finally, you can also begin your training with a question (i.e., Toastmaster hook #3 above).

Tell a story and make a point

For each teaching point you should consider using an anecdote, case study, or a related story. The audience will want to know how the story ends, and they are more likely to remember the story. If you haven’t conducted more than 1,000 audits, traveled all over the world, or have more than 25 years of experience–don’t despair. You can always interview other people on any topic to get their stories. If you are looking for tips on how to construct a story, Toastmasters comes to my rescue again. Here’s their recommended six-part structure for the Hero’s Journey:

  1. Setup
  2. Inciting incident
  3. Progressive complications
  4. Insight
  5. Climax and resolution
  6. Lesson

What kind of prop can you use for quality and regulatory?

In one of the paragraphs below, I mention a simple prop that you can use for training–product samples. I did this in one of our live-streaming YouTube videos where I explained how to review medical device labeling. But you can use other things in your environment. For example, the first public speaking course I ever had was taught by a man with Polio that used crutches. He used one of his crutches as a prop to demonstrate how he looked over a fence.

How often should you take breaks?

Students cannot maintain a state of alertness and attention indefinitely. Your body naturally cycles between higher and lower alertness every 90 minutes. After 90 minutes it becomes harder to focus and you need to take a break. If you can, splitting 90 minutes into two 45-minute sessions is even better. You can also experiment with two strategies for better instructor engagement: 1) conduct a “pop quiz” after a break to make sure the audience understood the information they were just taught, and 2) don’t be afraid to adjust the breaks slightly to coincide with a change in topic. Changing topics at a break allows you to repeat the most important points three times. The first time when you introduced a topic, the second time when you have concluding remarks at the end of a topic, and a third time after the break when you make sure the audience understood the material you presented before the break.

What kind of surprise will engage your audience?

There are two strategies for using a surprise: 1) promise to surprise them in the future, or 2) don’t tell anyone until you surprise them. The first strategy works best when you are trying to get people to watch until the end of the training. This is commonly used by YouTubers to get people to watch the video until the end. Unfortunately, this backfires because we can fast-forward to the end. I’m not suggesting that you shouldn’t surprise your audience, but the surprise needs to delight your audience. You might also need to surprise and delight your audience more than once. Even then, some of your audience will still nod off and completely ignore you. When this happens, throw a Snickers bar at the offending student.

snickers Instructor engagement is the secret to training effectiveness
This is an essential tool for any instructor. It functions as a tool to prod sleeping students awake, is small enough to cause minimal injury when thrown, serves as an emergency food supply, and is gluten-free.

How to force-feed students legal stimulants

If legal counsel recommends against using projectiles to encourage class participation, you might also consider one of my all-time genius ideas–consuming dangerously large quantities of caffeine. I was scheduled for a two-day course in Ottawa, but the day before I needed to perform an audit in Pennsylvania. My flight was the last flight into Ottawa, which arrived at approximately 1 o’clock in the morning. My arrival was delayed an additional hour in customs by the person in front of me who was trying to smuggle an extra carton of smokes into the country. Just before 4 a.m., my taxi arrived at the Albert at Bay Suite Hotel. The class started at eight in the morning. I made it to class on time, and the excessive consumption of several pots of black coffee helped get me to lunch. Then my legs started getting a little shaky. Fortunately, there was a convenience store next door that sold my favorite chocolate–the Dark Aero bar! After four of these monstrous doses of cacao, and another pot of coffee, I could have listened to the lecture on the Canadian Medical Devices Regulations all night. The only problem is that my hands are still shaking 15 years later.

aero bar Instructor engagement is the secret to training effectiveness
Hershey’s copied them, but the result was a mere shadow of Nestle’s greatness. Canadians know how to make junk food, tell a joke, and play hockey!

Why was the instructor engagement high in Ottawa?

Despite the physical handicap of sleep deprivation, I still learned a ton from my course in Canada. Here’s why:

  1. The instructors were both regulatory experts that were able to share anecdotes, case studies, and stories about real-world application of the Canadian Medical Devices Regulations. One of the instructors even worked for Health Canada.
  2. The audience was hyper-motivated to pass the course, because everyone in the class worked for a Notified Body that had sponsored them to take the course. In order to stay employed and get a raise, I needed to pass that course. If I failed the exam, I had to absorb the cost to travel back to Ottawa and retake the course in February (BRRRR!).
  3. The instructors brought more than a dozen medical devices to the class. These props gave us something to read, touch, and ask questions about. The instructors broke us up into small teams to study the labeling and instructions for use of each device. Even students from Japan, Europe, and Australia were familiar with some of the products. This was critical because we all needed to be able to identify incorrect Canadian labeling.
  4. The best instructor engagement tool used was humor. The instructor from Health Canada was hilarious. He had everyone laughing at his jokes for the entire course. Most of the jokes were not funny enough for a stand-up routine, but this was a mandatory regulatory course on Canadian regulations. Who would even expect a chuckle? Despite the strengths of these instructors, there is only one reason why I know the Canadian Medical Devices Regulations (CMDR), as well as I do. I use them every single week.

When students are forced to do homework, they will pay attention

After completing my CMDR training, I had to audit 162 days for BSI in 2011. Ninety percent of those 162 days were for companies that required a Canadian Medical Device License. This forced me to use the information I learned in the course. I was also consulting for companies at the same time I was auditing for BSI. Consulting clients hired me to prepare and submit the Canadian Medical Device License Applications for them. I also had to create procedures for Canadian Licensing, Incident Reporting, and Recalls. I spent another 60+ days in 2011 doing consulting, which helped me hone my knowledge of Canadian device regulations.

Teaching others will make you a guru

Most people are terrified to speak on any topic–even to a small group of coworkers. However, I believe that teaching others is the secret to becoming a guru on any topic. I was one of BSI’s instructors that taught the regulatory comparison course from 2010 to 2012, which compared the regulations of the USA, Canada, Europe, Australia, and Japan. Therefore, at least once a month, I had a classroom of 6-20 people asking me challenging questions about how to interpret and apply regulations from each of these countries to their products. I used every bit of knowledge I learned in that course in Ottawa, and I started using that knowledge immediately after the course. Peers, clients, and students challenge my knowledge of these topics every day. This is what makes you a subject matter expert. If you need to learn something about quality assurance or regulatory affairs watching a one-hour webinar, reading a blog, taking a five-day course, or shadowing another more experienced person is not enough. In the end, all of the above will get you to the level of barely competent!  If you want to master any topic, you need to practice instructor engagement and use everything you learn for several years.

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Risk Management Procedure (SYS-010)

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This risk management procedure pertains to the entire product realization process, and the procedure is compliant with ISO 14971:2019 and the EU MDR.

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The purpose of this 9-page procedure is to define requirements for risk management. The procedure was recently updated to reflect the changes in the ISO 14971, 3rd edition (ISO 14971:2019), the EU MDR, and we have incorporated references to our new Usability Procedure (SYS-048).

Risk Management SOP Risk Management Procedure (SYS 010)
SYS-010 - Risk Management Procedure
SYS-010, Risk Management Procedure - compliant with EN ISO 14971:2019. Includes templates for documentation of design risk management and process risk management. This procedure has been updated for compliance with ISO 14971:2019, ISO/TR 24971:2020, and Regulation (EU) 2017/745.
Price: $299.00

risk managment11 Risk Management Procedure (SYS 010)
Risk Management Training for ISO 14971:2019
Two-part Risk Management Training Webinar for ISO 14971:2019 - Part 1 of this webinar will be presented live on Tuesday, March 29 @ 9-10:30 am EDT. Part 2 of this webinar series will be presented live on Tuesday, April 5 at 9-10:30 am EDT. Purchase of this webinar series will grant the customer access to both live webinars. They will also receive the native slide decks and recording for the two webinars.
Price: $129.00

exam1 150x150 Risk Management Procedure (SYS 010)
20-Question Quiz for Risk Management Training Webinar on ISO 14971:2019
20-Question Quiz for Risk Management Training Webinar on ISO 14971:2019 - We updated our quiz for training effectiveness from a 10-question quiz to a 20-question quiz that is more comprehensive. Any person that purchases the 20-question quiz will receive a training certificate template and the answer key to our quiz.
Price: $49.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.

When is the Risk Management Procedure Webinar?

The Risk Management Procedure Webinar will be hosted on September 9, 2024 @ 10:30 a.m. ET. The webinar will be live on StreamYard, and you will receive login instructions if you purchased the training procedure prior to the scheduled live webinar. The webinar will also be recorded. You will be able to download the webinar from our Dropbox folder and watch the webinar as many times as needed–including the training of future employees.

What’s included in the purchase of this procedure?

The following documents are included with the purchase of this procedure:

  • What is included in the folder 1024x620 Risk Management Procedure (SYS 010)

This risk management procedure pertains to the entire product realization process from the beginning of design and development through obsolescence. The procedure is compliant with new EU MDR/IVD, ISO 14971:2019, and ISO/TR 24971:2020. This procedure is the primary document meeting the applicable regulatory requirements for risk management  This procedure applies to medical devices distributed in the United States, Canada and the European Union.

Design & Risk Management Plan

At the beginning of each design project a design plan is created. The design plan should include a risk management plan section or a separate risk management plan shall be created. The risk management plan only needs to cover from the beginning of the project to product release–not post-market risk activities. The risk management plan during the design phase shall include at least the following elements:

  1. hazard identification
  2. risk assessment
  3. risk control option analysis
  4. risk control verification of effectiveness
  5. benefit-risk analysis for each individual risk and the overall residual risks of the device
  6. process failure modes and effects analysis
  7. a risk management report summarizing the results of risk management activities

If you are interested in risk management training, our risk management training webinar is being updated for the second time. The previous update was in October of 2018. The new two-part webinar will be hosted on March 29, 2022 and April 5, 2022. Part 1 will cover Clause 1 through Clause 7.1, while Part 2 will cover Clause 7.2 through Clause 10. We have selected Clause 7.2 to begin the Part 2 of this webinar series, because it marks the beginning of the verification of the risk controls your company has implemented (i.e. – Post “Design Freeze”).

To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

 

managment review sample SOP Risk Management Procedure (SYS 010)

About Your Instructor

Screenshot from webinar 150x150 Risk Management Procedure (SYS 010)

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

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Management Review Procedure and Webinar – Free Downloads

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This management review procedure is an example of the procedures and webinars that we created for our turnkey quality system.

Who should attend the Management Review Procedure Webinar?

The management representative should watch the 36-minute procedure webinar, included at the top of this page, to help them implement this management review procedure. The longer training webinar is recommended for everyone else in top management. OEMs and contract manufacturers both need to conduct management reviews to ensure the effectiveness of the quality management system. The ISO 13485 standard and 21 CFR 820 both require that your company conduct a management review. Therefore, everyone in top management at a medical device company should watch this 41-minute management review webinar. If you are the management representative, you can’t afford to miss this opportunity. If you hate management reviews, you will like this method better.

How will this training webinar help you?

Does the CEO and CFO of your company complain about the length of management review meetings? The advice in this management review training webinar is intended to keep senior management engaged during management review meetings. Our speaker has performed hundreds of management reviews this way since 2003 and audited over one thousand management reviews. There are dozens of ways to conduct a management review, but only a few methods are simple, efficient, and foolproof. We recommend using our management review procedure and the corresponding template. They are free, and they will make your meetings shorter and more effective.

In 2012, the FDA Issued 219 findings against management responsibilities and the management review process. The management review meeting minutes may be officially “out of reach” until 2026, but there are FDA inspectors that will ask for this document anyway. Do you really want to be perceived as hiding something? Update your management review procedure now.

What’s included in this management review procedure bundle?

The webinar explaining the requirements for management reviews is being updated for 2024. Anyone that registered previously for the management review procedure and webinar will receive a free update. If you submit a new registration, you will get:

Management Review Procedure Content Management Review Procedure and Webinar Free Downloads

What you will learn from the management review training webinar:

Did you receive a nonconformity during your last audit, because you forgot to include one of these required items?

  1. Twelve Inputs
  2. Four Outputs
  3. Review of the Quality Policy
  4. Review of the Quality Objectives
  5. Review of the QMS effectiveness

This management review training webinar will teach you how to document the management review requirements in your meeting minutes and it will teach you how to delegate meeting preparation more effectively. The management team will not be bored in your next management review, and your meetings will improve quality AND the bottom line. You will also receive a copy of our management review procedure and the management review procedure webinar to help you implement the new procedure.

Do you want to learn more about procedure writing?

This management review procedure is just an example of how we created procedures for our turnkey quality system. If you are interested in learning more about how to write your own procedures (e.g., for manufacturing work instructions, installation, or service), we recommend reading our procedure case study on writing the management review procedure. We also include a procedure template as part of our Document Control Procedure (SYS-001).

About the Author & Webinar Instructor

Screenshot from webinar 150x150 Management Review Procedure and Webinar Free Downloads

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

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Regulatory submission plan webinar

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Learn how to combine your efforts to prepare a 510k and CE Marking submission in this regulatory submission plan webinar.

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In this Regulatory Submission Plan webinar you will learn how to “Combine 510k with CE marking submissions.” You will learn the basic changes made to the 510k submission process by implementation of the FDA eSTAR template and the changes to the CE Marking process resulting from Regulation (EU) 2017/745 entering into force. The elements that are common to each submission type have not changed, but the FDA eSTAR template has made the 510k submission process simpler, while CE Marking technical files for the MDR and IVDR have become far more complex. Most medical device companies are submitting a 510k first, but this webinar will show how to create a regulatory submission plan for both markets in parallel.

When is the Regulatory Submission Plan webinar?

This webinar was initially hosted live in 2015, and we re-recorded the webinar on April 4, 2022. The webinar will be updated and hosted live on December 5, 2024 @ 10:30 a.m. ET. The updated webinar includes revisions to the 510k process to reflect the implementation of the FDA eSTAR template and changes to the CE Marking technical file review process resulting from Regulation (EU) 2017/745 coming into force. We are also sharing lessons learned from companies that have struggled with both types of submissions recently.

Combine 510k and CE Technical File 2 Regulatory submission plan webinar
Regulatory Submission Plan Webinar
In this Regulatory Submission Plan webinar you will learn how to "Combine 510k with CE marking submissions." You will learn the basic changes made to the 510k submission process by implementation of the FDA eSTAR template and the changes to the CE Marking process resulting from Regulation (EU) 2017/745 entering into force. The elements that are common to each submission type have not changed, but the FDA eSTAR template has made the 510k submission process simpler, while CE Marking technical files for the MDR and IVDR have become far more complex. Most medical device companies are submitting a 510k first, but this webinar will show how to create a regulatory submission plan for both markets in parallel.
Price: $129.00

This webinar is included in the 510k course series. If you decide to purchase the 510k course at a later date, we will give you a credit for any of the paid webinars in the 510k course series that you have already purchased.

Who should watch this webinar?

  • Regulatory Affairs
  • Product Development / R&D

Why do companies submit a 510k today before CE Marking?

Usually we focus on the cost differences between a 510k and CE Marking or the submission review timeline to explain why companies submit a 510k before they apply for CE Marking. However, there are also technical reasons why a 510k submission will always be possible to submit first. The organization of the CE Marking technical file is totally different from the FDA eSTAR template, while the testing requirements for the USA and Europe are quite similar. The FDA prefers to receive full testing reports, while Notified Bodies require a summary technical document (STED). Therefore, you are able to submit a 510k to the FDA immediately after the last testing report is completed. In contrast, CE Marking requires that you prepare a STED that summarizes each testing report prior to submission. Your CE Marking submission also requires submission of your complete risk management file–including links to the testing reports that were used to verify effectiveness of the implemented risk controls. Therefore, you cannot complete your risk management file until all your testing is under way or completed. Finally, your post-market surveillance documentation and Clinical Evaluation Report need to be reference elements of your risk management file. These post-testing documentation activities create an inherent delay prior to the submission of a technical file for CE Marking. Therefore, a 510k is usually the first regulatory submission in your strategic marketing plan.

Will this Regulatory Submission Plan Webinar include other differences between a 510k and CE Marking?

There are many differences between a 510k and CE Marking submission that need to be included in your regulatory submission plan. We will be reviewing the following differences between these two submission types:

In addition, to the technical content required for a CE Marking submission, Notified Body auditors also have to verify the following elements during the audit process:

  • quality system documentation (only sampled during FDA inspections–not during as part of the 510k process)
  • supplier agreements and supplier auditing may be conducted, depending upon the ISO 13485 certification of the suppliers
  • training effectiveness and competency of employees
  • suitability of the infrastructure and work environment for manufacturing your medical device

What you get when you purchase the Regulatory Submission Plan webinar:

  • .CSV file containing a list of required elements for each submission type
  • Template for a Regulatory Submission Plan
  • Native Presentation Slide Deck
  • Login information for the live webinar (if you purchase prior to December 5, 2024)
  • Link to download the recording of this webinar on-demand (anyone in your company can watch again and again)

Do you need consulting advice?

If you have questions about your 510k submission or CE Marking technical file preparation, you can schedule a call with our Director of Sales i.e., Lindsey Walker, or Rob Packard using our calendly link on the Contact Us page.

About Your Instructor

Winter in VT 2024 150x150 Regulatory submission plan webinar

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

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Software as a medical device (SaMD)

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Can you combine the software development lifecycle with design controls when you are developing software as a medical device (SaMD)?

What is software as a medical device (SaMD)?

Prior to 1996, most medical devices did not include software. The devices that did have software were called electrical medical devices. Electrocautery devices, multi-parameter monitoring systems, and laparoscopic imaging systems are examples of electrical medical devices. However, when radiographic imaging systems began using digital sensors, the medical industry also started developing software to display, manipulate, and measure DICOM images. Those stand-alone software imaging tools were called software as a medical device (SaMD), because there was no electrical medical device sold with the software. To help differentiate the types of software, software in electrical medical devices is now called software in a medical device (SiMD). Then medical device companies began to develop algorithms to predict and diagnose for other types of data. Next artificial intelligence and machine learning was used to accelerate algorithm development. Now the field of software medical devices has exploded.

Along with the increase in the number of SaMDs on the market, there has also been an increase in the number of start-up medical device companies that are developing SaMD products.

Five characteristics of most SaMD start-up medical device companies

Medical Device Academy specializes in helping start-up medical device companies, and we see common characteristics shared by these MedTech start-ups. First, they are usually successful in demonstrating proof of concept for their software device within months. Second, the development team is typically virtual (i.e. everyone lives in a different state or even in different countries). Third, the development team does not include anyone with quality or regulatory responsibility. Fourth, the company has not implemented software design controls or started a design history file (DHF). Fifth, the company is not even aware of the existence of IEC 62304 –the international standard that defines the life cycle requirements for medical device software.

The above situation is quite common, but it is not a serious problem. These MedTech start-ups just need guidance on how to comply with medical device regulations without creating an overly burdensome quality system and excessive documentation. At the same time, these companies need to stay small, agile, and thrifty. Most people believe that the quality system and software documentation process slows down the development process, but the intent is to prevent mistakes and to help you plan the design and development of your SaMD so that the resulting software is safe and performs as you intended (i.e., efficacious). In order to create a quality system and software documentation process that is lean and efficient, there are some common pitfalls you should avoid.

When do you need to implement a quality system for software as a medical device (SaMD)?

When a quality system is required depends upon which market you are launching your product in first. If you are launching your product in Canada, you need a special kind of quality system certificate before you can apply for a Canadian Medical Device License (i.e. MDSAP Certificate for ISO 13485:2016). MDSAP stands for “medical device single audit program,” and there are only 16 organizations that can issue this type of certificate. If you are launching your product in Europe, you will go through your ISO 13485 quality system certification in parallel with obtaining the CE Certification of your SaMD. If you are launching your product in the USA, you do not need your quality system to be complete until after you obtain 510(k) clearance and you are ready to register and list with the FDA. You also do not need ISO certification for the US market. If your SaMD is a Class 1 device in any of these three markets, you may have fewer quality systems and regulatory requirements.

Regardless of which market you are planning to launch your product in, you should not invest in a complete quality system and then develop your SaMD. You should either develop both in parallel, or you should develop your SaMD first. The only processes that are really important to implement at the beginning of product development are 1) design controls, 2) software development, 3) risk management, and 4) usability engineering or human factors testing. You can wait to implement the other 20+ procedures until you are entering the design transfer phase of your design and development project.

Do you need separate procedures for design controls, change control, and software development?

If you are developing a complex system that includes hardware and software you should probably have three separate procedures. The reason for this is that there are different quality systems and regulatory requirements for changes to hardware and software. If you are only developing SaMD, then you can easily combine these three processes into one procedure. The following outlines the software documentation that should be covered in each stage of your design process:

Planning (Phase 1)

Design planning requires identification of the software risk classification (i.e. A, B, or C) in accordance with IEC 62304, and the software documentation level (i.e., Basic or Enhanced) for your software in accordance with the FDA guidance for software documentation. Regardless of what the software documentation level is for your SaMD, you will still need to develop the documentation required for the risk classification in IEC 62304–even if the FDA does not want to review all of that documentation in your 510(k) submission. You will also need to identify the regulatory pathway for your SaMD. Your design plan will identify the team members and each person’s role and responsibility. You plan should also reference your software development procedure and describe the software development environment.

Basic or enhanced documentation 1024x633 Software as a medical device (SaMD)
FDA eSTAR Screen Capture

Requirements (Phase 2)

This phase is when you should document you create a draft software description and create a draft software architecture diagram. The software requirements specification (SRS) must be documented in the second phase, but you should anticipate revisions as the project progresses. Software requirements should include data hazards, use specifications, security risks, and all of your test requirements. Typically, it is recommended to review your testing plan for verifying performance with a regulator in a pre-submission meeting prior to conducting your verification and validation testing–especially if animal preclinical studies or human clinical studies are required.

Specifications (Phase 3)

Design outputs are iteratively developed during the third phase. This is typically the longest phase of your development process, and the “Waterfall Diagram” is not an accurate depiction of the software development processes. The “V-Diagram” presented in IEC 62304 is a better representation of the software development process because you continuously repeat steps as you debug your code and add functionality to your software. Only the simplest firmware is written in a linear fashion without multiple debug and retest cycles, and lean product development methods (i.e. Agile programming) are intended to be iterative. This phase of development is complete when you conduct a “design freeze” and begin your verification and validation testing. Typically, companies that are developing SaMD can complete most of their unit testing and integration testing prior to the design freeze, but system validation may not be conducted until phase 4. Unfortunately, the unit testing and integration testing can only proceed so far if you have an embedded system (i.e. software embedded in hardware). If the SaMD requires human clinical studies, that software validation is performed during Phase 4. Phase 3 is when you should be documenting your software design specifications (SDS), unit testing, and integration testing. Any formative testing required for the user interface would be done during this phase. Formative testing may include: 1) evaluating very software functions, 2) developing directions for use, and 3) developing a training program for users. You should write testing protocols for system validation and usability testing during this phase as well. To help you prepare those protocols you will need to prepare a use-related risk analysis (URRA) and a cybersecurity risk analysis first. It is also an excellent idea to start drafting a software traceability matrix during this phase to ensure that each data hazard and SRS item is being addressed in your verification and validation plan.

Screen capture of Summative Protocol Template 1024x789 Software as a medical device (SaMD)

Verification & Validation (Phase 4)

Design verification and validation of your SaMD are completed during this phase. At the end of this phase, you should have a complete traceability matrix, you should create a summary report of your unit testing and integration testing, and you should create a system validation report–including any benchtop, animal, or human performance testing is conducted. You should also create a revision history document and a bug report identifying any known bugs in the software with a justification for why the software is safe to release with these bugs. This phase is also when you should complete your risk management file and your summative usability testing report. Finally, you need to complete a final draft of your user manual for the software that includes directions for use and the indications for use. When all of this documentation is completed, you are ready for your regulatory submission.

Software documentation attachments for an FDA eSTAR 1024x501 Software as a medical device (SaMD)

Regulatory Review (Phase 5)

The last phase of design and development process for software as a medical device (SaMD) is the regulatory review. The FDA review process involves the following sub-steps:

    1. Technical Review: Days 1-15
    2. Substantive: Days 16-59
    3. FDA Decision (AI Hold or Interactive Review): Day 60
    4. Additional Information (AI) Hold: Up to 180 days
    5. Interactive Review: Days 61-89
    6. FDA SE Decision: Day 90

Once you receive 510k clearance for your SaMD, then you can begin the final release of your product. You will need to update your “splash” or “about” screen for the software to include a Unique Device Identifier (UDI). The information will need to be uploaded to the FDA’s GUDID. You can assign the DI for the UDI anytime, but the GUDID data elements cannot be finalized until you have 510k clearance from the FDA. You will also need to manage revisions of your software for this minor change and revalidate the code. This type of change will not require a new 510k, because it is a minor device modification. However, you will need to review the FDA guidance on software changes for other types of software revisions you make in the future.

Should you outsource software documentation for software as a medical device (SaMD)?

You can outsource all of your software documentation for a SaMD, but the person(s) creating that documentation will still need the documents mentioned in phase 2. If you do not provide any documentation of hazards, a software description, or a crude sketch of your software’s architecture, it will be nearly impossible for anyone to create your software documentation. It is also extremely expensive to outsource software documentation. Even if you do outsource this task, you still will need to review and approve that documentation. Most people outsource tasks because they don’t know how to do it, but it is critical for medical device companies to learn how to document their software development because they will need to maintain that documentation when the software is updated to fix a software bug or to patch cybersecurity weaknesses. Everyone that is developing software for a SaMD should receive basic training on the requirements of IEC 62304 early in your project. Your team does not need to be an expert in IEC 62304, but you need to create draft documents that you can present to experts for feedback. Your team should also review all four of the guidance documents that the FDA released for software documentation:

  1. General Principles of Software Validation (2002)
  2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
  3. Content of Premarket Submissions for Device Software Functions (2023)
  4. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2023)
  5. Postmarket Management of Cybersecurity in Medical Devices (2016)
  6. Off-The-Shelf Software Use in Medical Devices (2019)

Creating your documentation is the hard part that your team should be doing while reviewing and editing your documentation is a great task to hire an expert consultant for your first SaMD project. This will ensure your team is writing the software documentation to the correct level of detail, and that you are not missing anything critical. Expert consultants can also provide you with templates for your software documentation.

Does software as a medical device (SaMD) require an electronic quality management system (eQMS)?

There are three types of quality systems: 1) paper-based quality systems, 2) virtual quality systems, and 3) an eQMS. Most start-up companies choose the virtual QMS option (i.e., #2) because they don’t want the extra cost of an eQMS. Some companies are afraid to abandon paper records, because they don’t want to validate record storage (i.e., Dropbox) and electronic signature software (e.g., DocuSign). However, if your company is smart enough to validate SaMD, you are smart enough to validate a virtual QMS too. The applicable standard for validation of software tools is ISO/TR 80002-2:2017. You can also purchase templates for software tool validation from Medical Device Academy. Companies are always asking for a referral of which eQMS system to purchase. If you would like to read our evaluation of the most popular eQMS software for medical device companies, please enter a request in our Suggestion Portal.

Who should be responsible for QA and RA for software as a medical device (SaMD)?

Quality and regulatory are two different functions, and it doesn’t always make sense to have one person be responsible for both requirements. The two primary standards that are applicable to the quality assurance of SaMD are 1) IEC 62304, and 2) ISO 13485. Anyone you are considering for the position of quality manager should be familiar with both standards, and they should be making sure that your development team is documenting the software verification and validation as you proceed through the iterative software development process that is typical of Agile software development teams. The person doesn’t need to be able to code software, but they should be able to help review software documentation and suggest changes. This person’s role is extremely important to make sure that software revisions are managed properly, your software is only released when all of the validation and revalidation are complete. This person should also be able to determine if a new 510(k) is required for software modifications.

The regulatory process is the preparation of the 510k submission and communications with the FDA. This is an activity that you will probably need to perform once every two years. The FDA requirements for a 510k change more frequently than once every two years, and it is extremely difficult to become proficient when you are filling out government forms so rarely. For these reasons, it is recommended to work with an expert regulatory consultant with SaMD experience until your company has enough software products and revisions that you need to file multiple 510k submissions each year. Therefore, a less experienced quality manager can gradually learn the regulatory requirements over time and they will need less help from a regulatory consultant each year.

How do you measure quality for SaMD?

A lot of software developers struggle with identifying quality metrics if they are developing software as a medical device (SaMD). There are many aspects of software development that you can measure. Here’s a list of examples:

  1. Customer feedback
  2. Velocity of Agile/Scrum sprints
  3. Coding errors
  4. What is the development lead time?
  5. How fast does the software load?
  6. Technical support requests
  7. Software configuration errors
  8. Duration of software validation
  9. Software validation documentation burden
  10. Post-market surveillance of use errors
  11. How many software bugs remain?

Do you need a corporate office?

Many MedTech companies are virtual companies, but the FDA will require a physical address to visit for an FDA inspection. FDA inspectors have visited the home of the company founder at other companies, but you probably will be more comfortable with an office space for the FDA inspector to visit. The FDA is unlikely to visit your company during the first year after you initially register your product. An inspection is more likely in the second year after initial registration and listing. Therefore, you might consider renting a co-working space where you can reserve a conference room if an FDA inspector visits. If you don’t have the funds to afford rent until after you launch your product, don’t worry. FDA inspectors are unlikely to visit so soon, and if they do–just relax and be honest about the situation. You are not alone.

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Are you a start-up device company that needs medical device consulting services and training for an FDA 510k submission?

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Medical device consulting services

Medical Device Academy, Inc. is a quality and regulatory consulting firm. We have nine (9) employees, and everyone works virtually from home. We specialize in helping small device companies prepare FDA 510k submissions using the eSTAR template, preparing FDA pre-submissions using the PreSTAR template, implementing new quality systems for compliance with the FDA, ISO 13485, and MDSAP, and conducting quality system audits. We also help with FDA US Agent services, CE Marking preparation, and Canadian License applications. Clients with urgent needs where time to market is critical turn to us. Our passion is teaching medical device professionals how to prepare for future regulations. For more information, please visit our website or our YouTube channel. We even wrote a 510k book, “How to prepare your 510k in 100 days,” because 100 days is how long your testing will take. It is only available as part of our 510k course series, and you can find all the details on our 510k course webpage.

Buy the 510(k) course series for $1,495

510k eSTAR Course 2024 Draft Home Page
510(k) Course Webinar Series
This is a 510(k) course series is continuously being updated with new webinars and new templates specifically for the FDA eSTAR pre-marketing submissions. This includes pre-submissions, 510(k) pre-market notifications, and De Novo Classification Requests. 28 new webinars have been recorded and we will continue to add more as the FDA makes changes. The price of this course is $1,495.
Price: $1,495.00

What do we charge for medical device consulting to prepare an FDA 510k submission?

We charge $17,500 for preparing a medical device 510k submission. This pricing does not include pre-submission meetings or the FDA user fees for FY 2025. A table with user fees is found below as well. A button for our standard pricing sheet of consulting services is provided below, along with a second button for our turnkey quality management system (QMS) pricing.

Consulting Services Pricing 300x67 Draft Home Page
Turnkey QMS Pricing 300x87 Draft Home Page

How long does it take to obtain a medical device 510k clearance?

Overall, the average is 125 days, but you can only estimate the time to obtain medical device 510k clearance by analyzing the data from recent, previous submissions for the same product classification. Every classification is different, and the average for each product classification ranges from less than 90 days to more than 180 days. We can explain the various options for reducing the review time (e.g., third-party reviewers), but the biggest delays are caused by the need to repeat testing because clients skipped a pre-submission meeting.

How much does a 510(k) cost?

The FDA user fees for medical device 510k submissions, 513(g) submissions, and De Novo Classification Requests are all discounted for qualified small businesses. To qualify, you must submit a small business qualification form (FDA Form 3602 or 3602A) each new fiscal year (October 1 – September 30). We recommend that every company submit on August 1 for the next fiscal year–even if they are unsure if they will submit. This advice alone will save your firm thousands of dollars. Below is a table listing all of the FDA user fees for submissions–both standard and small business fees.

FY2025 User Fees 1024x544 Draft Home Page

Medical device product classifications and regulatory pathways

The FDA regulatory pathway and other regulatory pathways are dependent upon the classification of the device. We provide regulatory pathway analysis services to clients for the US market, the European market, and the Canadian market. We also help you determine the testing requirements, identify potential predicates, and explain the quality system requirements for your type of device. This is typically included with our medical device 510k pre-submissions and De Novo Applications.

FDA substantial equivalence (SE) decision process

The process flow diagram in the video above may seem simple, but how you interpret each question can change the answer significantly. Sometimes, a few words or a single design feature can change the FDA reviewer’s decision when evaluating substantial equivalence. Many of these differences concerning interpretation become evident during the pre-submission meeting with the FDA. Following the wrong path will result in significant delays at best, and many clients discover that clinical testing and/or a De Novo Application is required due to changes in technological characteristics or due to a slight change in the indications for use.

Developing a verification and validation (V&V) testing plan

Having the right verification and validation testing plan is critical to timely FDA 510k clearance and approval of De Novo Requests. That’s why we prepare draft testing plans for clients, and then we ask the FDA for feedback on the testing plan during a pre-submission meeting. We use guidance documents, competitor submissions, and our experience with similar devices. However, we often learn something new from the FDA in every pre-submission meeting because the requirements constantly change.

Medical device 510k project management

Most people see meetings as a waste of time, but we try to conduct efficient, weekly, 30-minute meetings with medical device consulting clients. The purpose is to answer their questions, give them an update on the project status, and make sure there are no surprises that could delay the project’s completion. Typically, we are waiting for the final testing reports, such as 1) the sterilization validation report, 2) the sensitization testing report, or 3) the electrical safety testing report. For every project, we use the table of contents as a color-coded planning tool to track the status of every document needed for your submission.

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About Our Company

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This webpage provides history about our company and explains our approach toward quality and regulatory consulting.

Consulting services provided by our company

Our company is a quality and regulatory consulting firm. We have nine (9) employees, and everyone works virtually from home. We specialize in helping small device companies prepare FDA 510k submissions using the eSTAR template, preparing FDA pre-submissions using the PreSTAR template, implementing new quality systems for compliance with the FDA, ISO 13485, and MDSAP, and conducting quality system audits. We also help with FDA US Agent services, CE Marking preparation, and Canadian License applications. Clients with urgent needs where time to market is critical turn to us. Our passion is teaching medical device professionals how to prepare for future regulations. For more information, please visit our website or our YouTube channel. We even wrote a 510k book, “How to prepare your 510k in 100 days,” because 100 days is how long your testing will take. It is only available as part of our 510k course series, and you can find all the details on our 510k course webpage.

What does our company charge for medical device consulting and quality system procedures?

We charge $17,500 for preparing a medical device 510k submission. This pricing does not include pre-submission meetings or the FDA user fees for FY 2025. A table with user fees is found below as well. A button for our standard pricing sheet of consulting services is provided below, along with a second button for our turnkey quality management system (QMS) pricing.

Consulting Services Pricing 300x67 About Our Company
Turnkey QMS Pricing 300x87 About Our Company

We are affordable because we know your start-ups have “one egg and one basket.” We are casual. We like taking risks. We are irreverent. We make mistakes, but we learn from them. We want our work to be fascinating. We teach the most boring topic on planet Earth, but we refuse to be boring. We want to be remarkable, memorable, and fun to work with. Our team is primarily located in the Eastern Time Zone, with medical device consultants in North Carolina, Pennsylvania, New Jersey, and Vermont. We all work 100% remotely, and we always have.

Who is our ideal medical device consulting client?

We are a full-service medical device regulatory consulting firm. The name “academy” emphasizes our love for training. We specialize in helping entrepreneurs get their first product to market–regardless of whether that is a medical device 510k clearance or a De Novo Classification Request. Ideally, you are located in another country, and you need help understanding the requirements of the US FDA. The best time for you to contact us is at the early stages when you have a proof-of-concept prototype but are unsure what to do next. You also might be under-capitalized, and you need advice on how much to budget and how to use your limited funding most efficiently.

What do our quality and regulatory consultants do?

Most of our work is preparing regulatory submissions, but 20% of our work involves helping you implement your quality system. We can help you with your medical device regulatory submissions. We specialize in medical device 510k submissions, preparation of CE Marking Technical Files, and Canadian device license submissions. We also created a business unit that specializes in preparing and validating FDA eCopies for pre-submissions, 510k submissions, and De Novo Applications. Due to changes in the FDA eCopy policies, we no longer offer FDA eCopy services except to active medical device consulting clients. If you need to upload your own FDA eCopy, you can register for a Customer Collaboration Portal Account with the FDA so that you can upload your own submission documents electronically.

Most of our clients are small and mid-size medical device companies that need continuing education training and quality System Auditing for compliance. Clients with urgent needs where time to market is critical turn to us. Our passion is teaching medical device professionals how to prepare for future regulations and self-monitor compliance to avoid compliance remediation.

How is our company different from other quality and regulatory consultants?

Most medical device consultants work by the hour, while our firm has flat-fee pricing. We can do this because we specialize in a narrow niche–primarily medical device 510k submissions and De Novo requests. We also differ from independent consultants and law firms because we have designed and built medical devices. Rob Packard was CEO and co-founder of a medical device start-up in 2004.

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Hazard identification webinar

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In this hazard identification webinar you will learn multiple methods of identifying hazards, including use-related and software hazards.

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Hazard Identification Webinar ($79)

There are multiple methods for hazard identification, but most companies stop after using one method. In this webinar you will learn multiple methods for identifying hazards. The webinar training includes demonstrating hazard identification for multiple device examples. You will also learn how to identify use-related risks and software risks. Webinar attendees will receive a copy of our hazard identification template as well.

Mindmap for hazard identification Hazard identification webinar
Hazard Identification Webinar
There are several methods for hazard identification, but most design and development teams stop after using only one method. This webinar explains multiple methods for hazard identification, including methods specific to use-related risks and software risks.
Price: $79.00

Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.

When is the Hazard Identification Webinar?

This webinar is scheduled for August 29, 2024 @ 10:30 a.m. ET. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your risk management file or facilitating hazard identification for your device, we can help you on an hourly basis. Please contact Lindsey Walker for a quote.

What you will receive in the Hazard Identification Webinar:

  • Hazard Identification Template
  • Login information to live webinar (if purchased on or before August 29, 2024)
  • Recording of live webinar
  • Native PowerPoint Slide Deck

About Your Instructor

Winter in VT 2024 150x150 Hazard identification webinar

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

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