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Status of the European Medical Device Regulations?

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This article describes the status of the new European Medical Device Regulations, and it provides some advice for what you should be doing to prepare for the changes.

MudI 600x334 Status of the European Medical Device Regulations?

The picture above is not a picture of people on their way to the local maple sugar shack, trying to get a car unstuck during mud season in Vermont. It’s actually a photo of paid actors reenacting the European negotiations for new medical device regulation. The European Parliament is in the overcoat on the left. The four men on the right represent the various presidents–Greek, Italian, Latvian, and Luxembourg. The Dutch President is driving the horse team in the front in the hopes of getting unstuck in time for next Spring.

Yes, in a word, the negotiations are “stuck”!

My friend Erik Vollebregt did a wonderful job of summarizing the status of negotiations on April 30, in his blog posting. The best guess anyone has is that we might have a final version released next year in Spring 2016. It’s only two years later than I was expecting. I guess they encountered more mud than expected.

There are a number of issues that the member states appear to be stuck on:

  • Ingested products
  • Non-medical devices
  • Companion diagnostics
  • Non-viable human tissues and cells
  • Viable biologic substances
  • Reprocessing single-use devices
  • Genetic testing
  • Implant cards
  • Eudamed & UDI
  • Summary of safety & performance
  • Notified Bodies
  • Pre-market approval
  • Clinical investigations
  • Post-market surveillance
  • Market surveillance & vigilance
  • Reference laboratories
  • Hazardous chemicals
  • Classification rules
  • Governance & oversight

I’m not quite sure whether the remaining list of issues the member states agree upon is shorter than this or longer. Still, this list includes a number of fundamental principles that could dramatically change the nature of medical device regulation in Europe. We expect that many of these issues will be resolved with a compromise of some sort. Still, I suspect every medical device manufacturer with a CE Mark will be extremely busy from 2016-2019 revising their procedures, technical documentation, and training personnel on the new European Medical Device Regulations.

 What Should You Be Doing to Prepare?

  1. Update Your Quality System to ISO 13485:2015 Early – The second Draft International Standard (DIS2) for ISO 13485 was released in February, and the final version is expected to be published this Fall. The changes to ISO 13485 are minor, but audits by your Notified Body will be far less complicated if you upgrade your quality system to the new revision before you attempt to address the new European Medical Device Regulations.
  2. Strengthen Your Internal Auditing & CAPA Processes – Companies with strong internal audit programs and CAPA processes have fewer findings resulting from Notified Bodies. When you have multiple outcomes from a previous audit to close, your annual surveillance audits and recertification audits become longer and more complex. These findings must also be closed before a manufacturer may transfer a quality system or CE Certificate from one Notified Body to another. Therefore, strengthening your internal audit and CAPA processes will result in a shorter Notified Body audit, and you will find it much easier to transfer from one Notified Body to another–if your current Notified Body is no longer able to issue a CE Certificate for one or more of your products.
  3. Update Your Technical Files – Companies that have a Design Dossier are required to submit all changes to their Design Dossier for approval before implementation. Still, companies with a Technical File for a lower risk device have their technical documentation sampled periodically. A sampling of technical documentation allows companies to fall behind in their documentation of changes. Re-issue of new CE Certificates will require a more thorough review of these Technical Files that may not have been sampled in several years. Therefore, I recommend that companies allocate resources to updating technical documentation now so that there is less work to update the technical documentation for the new European Medical Device Regulations.
  4. Review Your Product Portfolio and Prune It – The more mature product lines become, the more likely it is that you have products you are maintaining that just aren’t selling. The cost of maintaining your technical documentation and updating everything for compliance with the new European Medical Device Regulations will be expensive. Therefore, you can save some money now and a larger amount of money later by eliminating any products from your CE Certificate that is not selling well. If you have customers that are still buying an older version of the product, now is the time to persuade them to transition to the current version of your product. You don’t want to maintain your Technical File for two versions of the same product.

Regardless of what compromises are made, the new European Medical Device Regulations are guaranteed to be the most substantial change in regulatory requirements that the medical device industry has endured since 2003–much more dramatic than the 2007/47/EC amendment to the Medical Device Directive (MDD).  

Will someone please buy the negotiators a pair of Bogs and a Subaru Crosstrek?

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Bogs Status of the European Medical Device Regulations?

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Webinar on 510k Submissions: Substantial Equivalence

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Section 12 is one of the most critical sections of your 510k submission. The FDA recently released a new guidance document to explain how substantial equivalence to a predicate device is determined. This webinar reviews that guidance document in detail.

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Our speaker explains what reviewers are looking for with regard to the intended use of your device. You will also learn how to compare each of the technological characteristics of your subject device with the predicate.

The presentation includes examples that will help you identify the best possible predicate. The examples illustrate the difference between intended use and indications for use. You will learn how to organize Section 12 of your submission so that the FDA reviewer is able to quickly verify substantial equivalence to the predicate you select. You will also learn how to properly use multiple predicates.

Join us for this webinar and you will learn the following critical information:

  • How to use the new FDA guidance and flow chart for determining substantial equivalence.
  • What is a split predicate and why it is not allowed?
  • Examples of devices with multiple predicates used correctly.
  • How and what to present for substantial equivalence in Section 12 of your submission.

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Who should watch?

    • Regulatory Affairs
    • Product Development / R&D

Please Note: Purchase of the webinar includes the Native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.

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Additional Resources for 510k submissions

If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.

About the Author

Rob Packard 150x150 Webinar on 510k Submissions: Substantial Equivalence

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. Robert 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 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’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 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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CE Marking Approval of a Medical Device (Case Study)

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This case study explains the process for CE Marking approval of a medical device under the EU MDD regulations.

CE marking case study CE Marking Approval of a Medical Device (Case Study)

For this case study, I selected the same hypothetical client that I chose for my case study on Canadian Medical Device Licensing and a 510k submission to the US FDA. The product is a cyanoacrylate adhesive sold by the makers of Krazy Glue®. This hypothetical client wants to expand its target market to include the healthcare industry by repackaging and marketing the product as a topical adhesive in Europe.

My client called to ask if I could help obtain CE Marking approval. In Europe, cyanoacrylate is a medical device when it is used as a topical adhesive. My first step is to determine the device classification as per Annex IX in the Medical Device Directive (93/42/EEC as modified by 2007/47/EC). Instead of relying solely upon the Directive, I use guidance documents published on the Europa website–specifically MEDDEV 2.4/1 rev 9 (the following link explains the European MEDDEV guidance documents – http://bit.ly/Whats-a-MEDDEV).

I identified three potential device classifications: 1) Class 1 as per Rule 4 (a non-invasive device which comes into contact with injured skin, if the device is intended to be used as a mechanical barrier, for compression or absorption of exudates); 2) Class 2a as per Rule 7 (a surgically invasive device intended for short-term use [i.e., < 30 days] are in Class 2a; and 3) Class 2b as per Rule 8 (an implantable device). These three applications match the three possible indications that I identified when I was reviewing classifications for Canadian Medical Device Licensing for this product.

If this device were not required to be “sterile,” then a Class 1 device could use the Annex VII route of conformity (i.e., self-declaration). However, even generic bandages are sold as sterile devices. Therefore, whether the device is a sterile Class 1 device or a Class 2a device, obtaining CE Marking approval will still require a Notified Body’s review and approval. The most common route would be the Annex V route of conformity. If my client were to launch their product as a “glue” for internal use, then the device would require an Annex II.3 Full Quality System Certificate or the combination of an Annex V Certificate and a Type Examination Certificate (i.e., Annex III).

STOP!

The previous paragraph was hard to understand, but the source of this jargon is Article 11 of the Medical Device Directive. This one section is the best practices in European legalese. If you want to make something almost unintelligible, copy Article 11. If you’re going to understand this stuff, a flow chart of the various routes to conformity is as good as it gets (still hard to understand, but fewer words). The following simplified table is what I use in my CE Marking webinar:

Classification Routes for CE Marking CE Marking Approval of a Medical Device (Case Study)

What you need to know…

My client only has one product family, and they are currently selling the product in Canada for external use by healthcare professionals—not as an implant. Therefore, the device is a Class 2a device requiring an Annex V certificate. My client will need to do the following:

  1. Select a Notified Body
  2. Submit a Technical File for review and approval
  3. Select a European Authorized Representative, because my client does not have a physical presence in Europe

Fortunately, my client already obtained an ISO 13485:2003 certificate with CMDCAS from their current registrar as part of the Canadian Licensing process. Therefore, the changes required for the Quality System consist of adding a few work instructions to meet European-specific requirements, such as vigilance reporting, creating a technical file, and performing clinical evaluations. My client also needs to add the European Requirements as an applicable regulatory requirement in the Quality Manual.

The more significant challenge is an assembly of a Technical File for submission. Since the product is already on the market in Canada, all of the technical requirements have been met. The documentation of these requirements now needs to be converted into a format acceptable to a Notified Body. There are three recommended strategies:

  1. Whatever the Notified Body prefers. Some of the Notified Bodies have a checklist of requirements for a Technical File. If such a list exists, the client should organize the Technical File in the same order.
  2. The GHTF STED format (GHTF/SG1/N011:2008). The Global Harmonization Task Force (http://bit.ly/GHTFSTEDGuidance) published this guidance document to standardize the format for submission of regulatory submissions. This is the format required for Class III and IV Canadian medical device license applications. This is also the format specified in the proposed EU Medical Device Regulations that is expected to be released in 2015.
  3. The NB-MED recommended format (NB-MED 2.5.1/rec 5). This document was created by the “Big 5” Notified Bodies. It provides a template in a two-part format for submissions. This was the format I used most often for auditing files and for creating new files. However, the proposed EU Regulations that are anticipated for release in 2015 are closer to the format of the GHTF guidance. Therefore, I no longer recommend this format.

My client chose option 3 for organizing their Technical File because they have full reports for each of the verification and validation tests that were performed, but creating summaries for each report would take longer than assembling a Technical File with copies of each of these full reports.

In all, I estimate that the overall timescale for completing this project is about 60 days–not including review by the Notified Body. Therefore, I suggested that the client obtain a quotation from their registrar for an Annex V Certificate. In addition, I suggested hiring a consultant from Medical Device Academy to help them with the preparation of a Clinical Evaluation. Before 2010, Clinical Evaluations were only required for high-risk devices. As part of the new MDD, clinical evaluations are now needed for all devices. Since the use of and risks associated with cyanoacrylates is well characterized in published literature, my client may use a literature search method for preparing a Clinical Evaluation as per MEDDEV 2.7/1 rev 3.

My client hired an Authorized Representative to handle European registration, receive customer complaints, and to act as a liaison with the Competent Authority in the event of an adverse event. An Authorized Representative Agreement was signed, and the Authorized Representative recommended a few corrections to procedures they reviewed as part of entering the contract with a new client.

The company also hired another clinical consultant from our firm to complete a literature search and write a Clinical Evaluation in four weeks. The complete Technical File was assembled and submitted to the Notified Body electronically with seven weeks of starting the project. The Notified Body’s first round of questions was received within six weeks. The client and I prepared responses to the questions in a week and submitted them to the Notified Body. Fortunately, the responses were thorough, and the Technical File was well-organized from the start. The Notified completed their final review and recommended the product for CE Marking within three more weeks. The Notified Body conducted two-panel reviews to verify the technical, regulatory, and risk aspects of the submission. Finally, the Annex V certificate was received 12 weeks after the initial submission of the Technical File.

If you are interested in additional training or assistance with CE Marking of medical devices, please email Rob Packard (mail to: rob@fdaestar.com). We have standardized procedures to meet each of the requirements in the European Regulations and a couple of webinar recordings that explain both the Medical Device Directive and how to create a technical file or design dossier.

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Combining Risk with Design

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This webinar introduces a new tool for documenting both product risk management and design controls in a combined planning template.

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Combining Risk with Design in a Traceability Matrix

Addressing design controls and risk management requirements separately is no longer an option. When design controls were first required, 1994 for ISO 9001 and 1996 for the FDA, there was no medical device risk management standard yet. ISO 14971 was first released in 2000, and the risk management process needs to be integrated with your design process. The webinar will teach you how to combine risk with design in a simple traceability matrix. The matrix also addresses the challenging expectations for CE Marking. This tool can also be applied to other products that are pharmaceuticals, biologics, combined drug/device products, and non-medical products.

The Failure Mode and Effects Analysis (FMEA) has been used for decades as the most popular tool for documenting risk analysis. The FMEA remains the best tool available for process risk analysis, but it does not adequately satisfy the “state of the art” requirements for risk management of medical device design and development. A new approach is needed.

In this presentation, our speaker reviews the global regulatory requirements for risk management and design of medical devices—including EN ISO 14971:2019 and the European Medical Device Regulations. You will also learn how to perform post-market surveillance and post-market clinical follow-up studies to ensure that risk management remains effective.

Join us for this webinar as our speaker helps you combine your product risk management activities with your design and development process.

This product risk management webinar shows you how to combine risk with design controls:

  • Requirements for design history file & risk management file
  • Scheduling risk management as part of design plan
  • Possible tools for risk assessment
  • An alternate risk management solution for improved hazard traceability
  • Post-Market Surveillance requirements and Writing an IFU

Are you interested in product risk management training?

If you are interested in training specific to risk management or design controls training, please visit the following pages:

Who should watch this webinar on combining risk with design?

  • Anyone Responsible for Design Controls
  • Anyone Responsible for Product Risk Management

Please Note: Purchase of the webinar includes the Native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.

This webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):

Webinar on Combining Product Risk Management with Design Controls2 Combining Risk with Design
Webinar - Combining Product Risk Management with Design Controls
This webinar introduces a new tool for documenting both product risk management and design controls. This tool is a simple traceability matrix, but it also meets addresses the challenging expectations for CE Marking. This tool can also be applied to other products that are pharmaceuticals, biologics, combined drug/device products and non-medical products.
Price: $129.00

Exam and Training Certificate available for $49.00:

Training Effectiveness Exam4 Combining Risk with Design
Exam - Combining Product Risk Management with Design Controls
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00

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About Your Instructor

Rob Packard 150x150 Combining Risk with DesignRob 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.

Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone at 802.281.4381 or by email.

You can also follow him on Google+, LinkedIn, or Twitter.

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Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring

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This webinar explains how auditors can investigate unexpected increases in bioburden as part of a bioburden failure analysis that will be used to implement containment, corrections, and corrective actions.

Every medical device company with a controlled environment and sterilized products is required to monitor bioburden and to implement process controls to ensure that bioburden remains within the validated limits. Unfortunately, there are so many possible sources of bioburden it is easy to have a sudden increase (i.e., spike) in the bioburden of raw materials, finished devices, or the controlled environment. Human error is usually blamed, but retraining people is not an effective corrective action. You need to design solutions that eliminate the need for human perfection. When a spike occurs, what do you do?

This webinar will help you pinpoint the actual cause of your bioburden problems. Identifying the actual cause of quality issues is critical to developing effective corrective actions. If you do not narrow the potential causes down to the actual cause or causes, then you will waste time and money implementing solutions you didn’t need. If miss the actual cause of exceeding your validated bioburden limits, then your corrective actions will not be effective and you will need to re-open your CAPA or initiate a new CAPA. You may also be forced to recall non-conforming products.

In this presentation, our speaker explains how to use the process approach to auditing in order to identify the root cause for excursions above established bioburden limits for 1) raw materials, 2) finished devices, and 3) controlled environments. It’s easy to think of ways your process controls could have failed, but you will save time and money if you can identify how your process controls actually failed.

Join us for this webinar as our speaker teaches you how to use your auditing skills to investigate the cause of exceeding validated bioburden limits.

This webinar covers:

  • Important environmental monitoring data to collect and analyze
  • Most common reasons for exceeding validated bioburden limits
  • Containment and Corrections
  • Corrective Actions & Preventive Actions
  • Training & Quality Objectives

Who should watch?

  • Internal Auditors and Supplier Auditors
  • Anyone Responsible for Controlled Environments
  • Anyone Responsible for Investigation of Bioburden Failure Analysis

Please Note: Purchase of the webinar includes the Native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.

Bioburden Failure Analysis 1024x729 Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring

This webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):

Bioburden Failure Analysis Webinar 300x225 Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring
Bioburden Failure Analysis Webinar
This webinar explains the process for auditing the environmental monitoring process and controlled environments. The recording will be sent in a separate email and this product includes a copy of the native PowerPoint slide deck.
Price: $129.00

Exam and Training Certificate available for $49.00:

Training Effectiveness Exam4 300x223 Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring
Exam - Bioburden Failure Analysis
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00
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About Your Instructor

Home page video cropped 150x150 Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoringRob 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. 2009-2012, 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 802.281.4381 or by email. You can also follow him on YouTube, LinkedIn or Twitter.

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Validating Bioburden Limits

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This article explains the process for setting and validating bioburden limits, and you will learn when investigations are needed. 

Last week, I was in Europe reviewing product specifications with a potential contract manufacturer for a medical device implant. Due to the raw materials that the contract manufacturer currently is using for a similar product, bioburden levels are higher than we can accept. The company uses an ISO Class 7 cleanroom for assembly and packaging, which is clean enough for these implants, but the molded components used for the assembly are not clean enough.

Validating Bioburden Limits Validating Bioburden Limits

The average bioburden is 220 CFU/device (i.e., colony-forming units/device), and the maximum observed bioburden exceeded 500 CFU/device. We want to use a lower dose range of gamma radiation to prevent the deterioration of bioabsorbable plastics, but a lower dose range requires that the average bioburden never exceed 100 CFU/device.

There are quite a few Clauses in ISO 13485 that differ from ISO 9001. One example is Clause 6.4–Work Environment. Subsection 6.4(b) states, “If work environment conditions can have an adverse effect on product quality, the organization shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions.” This is the applicable clause of ISO 13485 related to setting bioburden limits. Unfortunately, this vague requirement does not explain how to establish or validate bioburden limits.

Rule of Thumb for Setting Limits

One of my microbiologist friends recommends using the following “rule of thumb”: +2 sigma for alert limits and +3 sigma for action limits. This rule of thumb assumes that you are performing data analysis of bioburden and that you have calculated a “sigma” value for the standard deviation. There are a few problems with the “rule of thumb” approach.

First, this method assumes a normal distribution and a controlled process–which bioburden seldom is. Second, the cleanliness you need for your product and the cleanliness your controlled environment is capable of are not always appropriately matched. In my example, we need the finished device to have a bioburden of <100 CFU/device before gamma sterilization. Molded parts are essentially bioburden free due to the hot temperatures of the parts ejected from the mold. Unfortunately, molded components attract dust like a magnet. Therefore, how you handle and store molded parts is important to the bioburden of the molded parts.

Which factors affect bioburden?

For this example, we have three aspects critical to the final bioburden limit of the finished medical devices.

  1. How are the molded parts handled and stored?
  2. Are molded parts cleaned before assembly?
  3. What is the cleanliness of the work environment where the device is assembled?

The cleanliness of the molding environment matters, but parts can fall into a container that keeps the parts clean. It also matters how molding machine operators handle the parts. Gloves should be used, and typically the container the parts are in will be placed in an outer bag for storage. It is possible to clean molded parts with ultrasonic cleaning before assembly, but if the parts are kept clean after molding, this is unnecessary.

For your assembly operation, you need an environment with suitable cleanliness. Sometimes a controlled environment is sufficient. Other times a certified cleanroom is more appropriate. In either case, it is important to control the bioburden in the assembly area to a level that meets the needs of the most critical product assembled in that area. Cleanroom procedures, the design of the cleanroom, and your cleaning/sterilization processes should match the needs of the product. Fortunately, cleanroom procedures and bioburden limits for cleanrooms are well established in ISO 14644-1 (e.g., for an ISO Class 7 cleanroom, particles ≥ 0.5 microns must be fewer than 352,000). If you have devices of different types in the same manufacturing area, you must plan according to the most critical needs.

Validating Bioburden Limits

After establishing your bioburden limits, you need to validate these limits. Once again, cleanroom validation has established ISO Standards to follow. The more challenging validation is a validation of the bioburden of parts and the final assembly. It’s important to validate the component levels first to reduce the variability of inputs to the final assembly process. Typically the first step is to perform data analysis of other molded parts produced in the same molding area by the same operators. If this data meets your needs for cleanliness, then further measures for controlling bioburden may not be needed. However, if you need to reduce bioburden (i.e., bioburden failure), you might consider measuring parts at critical control points. The goal is to identify where the bioburden is being introduced. This analysis is typical of the type of root cause investigation performed when bioburden increases for unexplained reasons.

Once the sources of bioburden are identified and quantified, process controls should be implemented to reduce bioburden. Gloves, double-bagging of product, and keeping containers covered during the molding operation are typical risk controls that may be implemented. To validate the effectiveness of these measures, you should write a bioburden validation protocol that evaluates each of the following aspects:

  1. lot variability of component bioburden
  2. operator variability for assembly
  3. variability in the cleanliness of the assembly area
  4. number of operators in the assembly area
  5. duration of the manufacturing lots

After you have validated the bioburden limits for the components, then the same process should be conducted for the final assembly of the product. A sampling of bioburden after transfer to the assembly area and before assembly begins should be done. This is important because often, improper storage of components and/or failure to remove and clean outer packaging will contaminate the parts and your assembly area.

process validation webinar Validating Bioburden LimitsIf you are interested in learning more about process validation, please download the process validation webinar. We also published a blog on sterilization and shelf-life validation for 510k submissions.

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Process Validation Avoiding Nonconformities, Complaints, FDA 483s and Recalls

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This webinar will help you prepare for FDA inspections, ISO Certification audits and customer audits by improving your process validation. More importantly, the presentation will help you avoid nonconforming product, audit nonconformities, complaints, FDA 483s and recalls.

Some of the largest and most expensive recalls ever were caused by inadequate process validation. The reason is because the defective product that process validation is supposed to prevent cannot be verified by inspection. That’s why process validation is required, and that’s why reviewing validation is the most critical element of production and process controls—one of the four major quality systems the FDA focuses on for inspection.

In this presentation, Rob Packard discusses the most important aspects of developing a Master Validation Plan, validation protocols, and validation reports. You will learn how to audit your own process validations to identify weaknesses, and you will learn how to use validations as part of your Corrective And Preventive Action (CAPA) process.

This webinar covers:

  • What needs to be in a Master Validation Plan
  • What are the most common FDA 483s related to validation
  • Critical aspects of designing an IQ, OQ, and PQ
  • Guidance documents for process validation
  • Auditing process validation

process validation webinar Process Validation Avoiding Nonconformities, Complaints, FDA 483s and Recalls

This webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):

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Process Validation Avoiding Nonconformities, Complaints, FDA 483s and Recalls
Includes Native PowerPoint Presentation
Price: $129.00

Exam and Training Certificate available for $49.00:

Training Effectiveness Exam2 Process Validation Avoiding Nonconformities, Complaints, FDA 483s and Recalls
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About Your Instructor

Medical Device Academy Robert Packard Process Validation Avoiding Nonconformities, Complaints, FDA 483s and RecallsRobert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including 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 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’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.

Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email.

You can also follow him on Google+, LinkedIn or Twitter.

 

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Remote auditing and supplier auditing webinar

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This remote auditing webinar reviews the strategies and techniques for conducting remote supplier audits that will conserve your precious resources of auditor time and money.

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Our presenter provides real-life experiences, examples, and tips for remote auditing and supplier auditing. Rob Packard, subject matter expert and founder of Medical Device Academy, reviews a number of topics in this 40-minute webinar. This webinar was originally recorded on February 25, 2015. However, we will be recording an updated remote auditing webinar on July 23, 2020. We also have a 10-blog series leading up to that updated webinar. Finally, we will be releasing a book on Amazon in August related to remote auditing. Anyone that has purchased this webinar previously will receive free access to the updated webinar too. The updated webinar will also automatically come with a new Remote Auditing Work Instruction (WI-002).

Remote Auditing:

  • When to or when not to conduct remote auditing
  • Examples of remote auditing
  • Allocation of resources
  • Auditor communication during remote audits
  • Recording remote audits
  • Work instructions for remote auditing
  • Risk evaluation of the ability to support remote audits

Supplier Auditing:

  • Purpose of supplier audits
  • Can I justify fewer supplier audits?
  • Can you justify more supplier audits?
  • Costs of poor quality
  • 4 most common auditing methods
  • Prioritizing supplier audits
  • Risk-based approach
  • Strategic selection of auditors
  • Use supplier audit template
  • Supplier audit agenda
  • Auditing Supplier Corrective Action Request (SCAR) closure

Other Resources

You may be interested in our Quality Audits Procedure (SYS-021). That procedure includes the following documents:

  • Quality Audits Procedure (SYS-021)
  • Audit Log (LST-007)
  • Supplier / Internal Audit Report Template (TMP-003)
  • Opening & Closing Meeting Checklist (TMP-035)

You may also be interested in our procedure for Supplier Quality Management (SYS-011). That procedure includes the following documents:

  • Supplier Quality Management (SYS-011)
  • Approved Supplier List (LST-003)
  • Supplier Evaluation Report Template (TMP-002)
  • Supplier-Internal Audit Report Template (TMP-003) 
  • New Supplier Approval Request Form (FRM-005)
  • Supplier Nonconformity Report Form (FRM-006)
  • Supplier Quality Agreement (FRM-037)
  • Supplier Nonconformity Report (SNCR) Register (LST-004)

On July 23, 2020, we are also releasing a new Remote Auditing Work Instruction (WI-002). The work instruction will be sold with the updated webinar as a bundle.supplier audit graphic Remote auditing and supplier auditing webinar

This remote auditing webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):

Supplier Auditing 150x150 Remote auditing and supplier auditing webinar
Remote Auditing Webinar and Supplier Auditing
This webinar is intended to teach auditors how to perform a supplier audit and how to conduct remote auditing (i.e., desktop auditing). A link to download the recording is delivered via AWeber in an email. This webinar will be updated on July 23, 2020. The updated webinar will also automatically come with a new Remote Auditing Work Instruction (WI-002).
Price: $129.00

Exam and Training Certificate available for $49.00:

exam1 150x150 Remote auditing and supplier auditing webinar
EXAM - Supplier Auditing & Remote Auditing
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00

You might also be interested in our Supplier Audit Tool Kit.

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS Remote auditing and supplier auditing webinar

About Your Instructor

Rob Packard 150x150 Remote auditing and supplier auditing webinar

Robert 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. Robert was a senior manager at several medical device companies—including 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 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’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 802.258.1881 or by email. You can also follow him on Google+, LinkedIn, YouTube, or Twitter.

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Updates on Electrical Safety Standards for Medical Devices-IEC 60601

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This blog summarizes updates on electrical safety standards for medical devices-IEC 60601.

electrical saftey 1 Updates on Electrical Safety Standards for Medical Devices IEC 60601

OSHA finally approved some Nationally Recognized Test Laboratories (NRTL) to AAMI ES 60601-1 (equivalent to IEC 60601-1 edition 3.1 or 3rd ed + A1). Leo Eisner posted a blog summarizing this change (http://bit.ly/OHSA-NRTL-Approval-Update) on January 7, 2015. The blog identifies which labs can issue NRTL Marks and which test labs have OSHA approval in progress. UL 60601-1 is still an approved standard that an approved NRTL can issue an NRTL test mark to, but a few of the NRTLs are now authorized to issue an NRTL Mark to AAMI ES 60601-1 3rd edition + Amendment 1.

The best place to confirm if a Safety Test Lab is an approved NRTL for your medical device is by confirming the notifications published in the U.S. Federal Register. You can also visit the OSHA NRTL website (http://bit.ly/OSHA-NRTL), but the OSHA website is updated less frequently. Eventually, UL will formally announce the withdrawal of UL 60601-1, and OSHA will take steps to withdraw that Standard from their list of Approved Standards.

On January 14, 2015, Leo Eisner posted a second blog (http://bit.ly/IEC-60601-2-52-amd1-ed1) on the topic of IEC 60601-2-52 Medical beds as a pre-release. He discusses the actual changes between the 1st edition and 1st edition + A1. This version is the pre-release before the updated Standard is issued as an International Standard (IS), and it is currently available as a Final Draft International Standard (FDIS). IEC website (http://bit.ly/buy-IEC60601-2-52-amd1-ed1) states: “By purchasing this FDIS now, you will automatically receive, also, the final publication.” The voting period ended on February 13, 2015, and the FDIS should be published shortly after (forecasted to be published on March 27, 2015).

Leo’s blog summarizes each of the changes to the Standard. Among the changes, there is a specific requirement to include hazards related to patients taller than 185 cm (like me). These hazards should be included in the risk management file. The new symbols required to identify the requirements for an “adult” are below: 

electrical Saftey 2 Updates on Electrical Safety Standards for Medical Devices IEC 60601

I find this new symbology particularly interesting because there are many medical devices where users frequently select the incorrect size for the patient. Consistent internationally recognized symbology for weight and height would be helpful for these devices, and bariatric specialty devices could benefit from the use of the last symbol.

If you need additional support for any of the IEC 60601 series of standards, please contact Rob Packard by email or phone (+1.802.281.4381) to discuss your specific needs.

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Postmarket Surveillance Webinar – Europe and the USA

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On February 9, 2023, we are hosting a postmarket surveillance webinar on the EU requirements and USA requirements [Registration Form @ Bottom of Page].

Post market surveillance dashboard 1024x488 Postmarket Surveillance Webinar Europe and the USA

The biggest change in the European CE Marking process is an increased emphasis on postmarket surveillance. When audits were conducted by joint inspection teams from the Competent Authorities in Europe, the auditors discovered that very few of the devices with PMCF Plans were completing those PMCF plans. The most common reason was that they were unable to gather enough data due to an insufficient number of respondents. In some cases, the Notified Bodies were forced to suspend CE Certificates for those devices. The EU regulations now contain a requirement in Annex III for Postmarket Surveillance Technical Documentation. Every company with a CE Marked device suddenly had to update their Technical File procedure and Postmarket Surveillance procedure. Everyone was also overwhelmed by the work required to conduct postmarket surveillance and postmarket clinical follow-up (PMCF).

What automated tools are available to help conduct postmarket surveillance?

In an effort to reduce the labor required for postmarket surveillance, software companies have created new products that automatically download adverse event and incident reporting data from various websites (e.g., MAUDE). The best software services allow you to create a customized dataset for each product family you sell. Then you can save the dataset and repeat the search for PMS data without recreating the search parameters. This ensures that the search method is identical each time and that the labor required to create the search parameters is only required the first time. In our live postmarket surveillance webinars on February 9th, we will demonstrate (i.e., Basil Systems) how to create these customized datasets and use them to create quarterly PMS reports semi-automatically. We will show you how to document your search parameters in your postmarket surveillance plan. We will also show you how to supplement the database searches with your own postmarket clinical follow questions.

What are the differences between European and USA postmarket surveillance requirements?

On January 5, 2023, Rob Packard was a guest on the Easy Medical Device Podcast hosted by Monir El Azzouzi (the video version is not yet published on YouTube Channel). The topic of discussion was “Postmarket Surveillance for the US Market.” This was an intriguing topic because the FDA requirements are very different from Europe and the rest of the world–especially for Class II devices that require 510(k) clearance. Therefore, as a follow-up webinar, we will discuss the US FDA requirements for PMS in our afternoon webinar on February 9th. We will discuss the EU requirements for PMS in our morning webinar.

When will the live postmarket surveillance webinar be hosted?

On February 9th, we are hosting a postmarket surveillance webinar in the morning (8:00 am EST) for the EU requirements. In the afternoon (4:00 pm EST), we are hosting a second webinar explaining the PMS requirements for the USA. If you register below, you will receive links to both webinars for live participation. We will also be posting the recording of the live webinars on our YouTube channel the following week.

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS Postmarket Surveillance Webinar Europe and the USA

About Your Instructor

Rob 150x150 Postmarket Surveillance Webinar Europe and the USA

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 2009-2012, 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 LinkedIn or Twitter.

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