Search Results for: 13485

Implementing the ISO 13485 Standard: Objectives

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By Guest Blogger, Brigid Glass

The author discusses implementing the ISO 13485 standard, including seven questions to clarifying your objectives and six considerations in shaping your objectives.%name Implementing the ISO 13485 Standard: Objectives

Implementing ISO 13485 is such an enormous undertaking for an organization that it pays to approach the planning strategically to ensure that all objectives are met.  Often, some objectives are made explicit, and others are unspoken. It is worth taking the time to ensure that all objectives are clearly stated to achieve the outcomes you want. Begin with the end in mind. Then, ensure that you are taking the organization with you, and you are all headed to the same destination.

7 Questions to Clarify Your Objectives
  1. What are your regulatory drivers for ISO 13485 implementation? Are there dates associated with marketing plans that you need to take into account? Are there other regulatory requirements that need to be built into the QMS and the implementation plan, (e.g., incident reporting for Canada or a Technical File for CE marking?)
  2. What other regulatory requirements must you meet to get into international markets? ISO 13485 requires that you meet applicable regulations for each market, such as a training procedure to address 21 CFR 820.25, a post-market surveillance plan to address CE Marking requirements, and a Mandatory Problem Reporting Procedure for Canada.
  3. If you are a supplier to medical device manufacturers, what do your customers expect of your QMS? If they haven’t made this explicit already, ask them. Meeting their needs and their audits of your system may be as important to you as the certification audit.
  4. Do you want to achieve business improvements by implementing a QMS? If you include this in your stated objectives, and everyone “buys into” the program, then you will build procedures that deliver business improvements, rather than just being regulatory overhead.
  5. Do you have real buy-in from your CEO? You may have buy-in for certification, but if you don’t already have a regulated QMS, does she or he fully understand the cultural change that he or she must lead? If not, make this one of your unwritten objectives and keep it front of mind.
  6. Do you have organizational buy-in?  Ensure that it is clear who owns each process, and that those process owners have the ultimate responsibility for the compliance of their process and ownership of documentation that is created for those processes. Keep the project progress visible. Develop a communication plan with its objectives and targets, even if your organization is small.
  7. Do you want to align with other systems? If you already have a QMS, you will want to integrate ISO 13485 compliance with that. Do you also need to implement ISO 14971, the risk management standard? Since you are going to be doing this much work on your QMS, maybe you could take the opportunity to align it with your health and safety or environmental management systems.
Timeframes and Trade-offs

How long it takes to implement ISO 13485 will be covered in another blog soon.  Six months is a workable rule of thumb.

So what do you do if you don’t have that long, and have to meet a pressing deadline?  Or you don’t have the resources available to implement, as well as you want in the time available?  Compromises have to be made, and now it’s necessary to set short-term and long-term objectives.

6 Considerations in Shaping Your ISO 13485 Standard Implementation Objectives

If you are constrained from structuring the implementation project ideally, the following considerations below will assist you in shaping your objectives:

  1. Get a qualified consultant who understands your business. If you have a large company, find someone who spends more of their time working with corporates, and vice versa for a small company.
  2. Throw perfectionism out the window. The goal is not perfect procedures. The essence of a Quality System is documentation to explain the intent, records to capture reality, internal auditing, and monitoring to identify the gaps and CAPA to improve and maintain effectiveness. The Deming Plan-Do-Check-Act cycle assumes that you are never perfect.)
  3. Accept that you then have another round of work to do to improve procedures.
  4. Organizational buy-in is even more critical. Be very careful about setting expectations. Adjusting to the extra requirements of a regulated QMS is already tricky. In these circumstances, you may be asking people to live with procedures that are not as usable as they would like.
  5. Be especially careful to ensure that the auditor can tick off all the essential points, and find how you have fulfilled the requirements without hunting too hard. All the required procedures and records must be in place. It’s more important to address 100% of the requirements than to perfect 80% and skip the last 20%.
  6. Accept that there may be nonconformities that have to be dealt with after the certification audit. Set the organizational expectation around this and build time for it into your schedule. Ask your certification body early to tell you the timeframe for dealing with nonconformities.
Setting Expectations

Objectives need to be communicated clearly to everyone in the organization. For a project (and many other things in life),

Satisfaction (or Disappointment) = Actual Result – Expectation

The certification audit is not the end. You will still need people to align their effort into making the implementation succeed after the pressure and obvious deadline of the certification audit has passed.  Setting their expectations appropriately early in the project is essential to keeping their (and your) motivation going. This is especially important if you are building your QMS, short on time or resource, and therefore know that you need to do a lot of work in the year following certification to develop improved workable procedures and generate a recorded history of compliance.

 

This blog is part of a series of blogs that leads up to our Roadmap to Iso 13485 Certification Courses

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FDA 510k Consultant Team

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Below you will find biographies and contact information for our FDA 510k consultant team, the human factors team, and the sales team.

Quality Assurance & Regulatory Affairs Consulting Team Services

Our consulting team offers services in three key areas:Icons 103x300 FDA 510k Consultant Team

  1. Regulatory Submissions (e.g., Breakthrough Device Designations, 513(g) submissions, Pre-Submissions, 510k submissions, Human Factors Documentation, De Novo Applications, CE Marking Technical Files, and Canadian Medical Device License Applications)
  2. Regulatory Compliance (e.g., mock FDA inspections, ISO 13485 certification, and CAPA)
  3. Continuing Education Training – webinars, public and private in-house training courses.

To learn more about our consulting team and the services we provide, to schedule a call, or to request a proposal, please contact Lindsey Walker, Director of Sales, at +1.802.989.3939 or by email at lindsey@medicaldeviceacademy.com.

Medical Device Academy has grown over the years, and we are continuously adding new experts to our team. Interested in Joining our Team? Click Here for Consulting Opportunities.

Our FDA 510k Consulting Team, Human Factors Team, and Sales Team

We have nine (9) full-time employees. Three employees are qualified lead auditors, and we have a team of subcontractors that include additional qualified lead auditors. Our permanent, full-time employees are listed below in the order that they joined our team. The titles for our FDA 510k consultants are based upon the number of 510k submissions they have submitted and were successfully cleared–not the years of experience. Consultants with five (5) or more cleared 510k submissions are Sr. Regulatory Consultants, and consultants with less than five (5) cleared 510k submissions are Associate Regulatory Consultants.

Our Consulting Team Button 300x84 FDA 510k Consultant Team

Photo of Tifany Walker Chesser 150x150 FDA 510k Consultant TeamTifany Chesser – Human Factors Team

Tifany is an Executive Admin for Medical Device Academy. She reports to Matthew Walker on the Human Factors Team, she is responsible for scheduling meetings with the President, and she assists the sales team with data entry. She also helps with the preparation of 510(k) submissions and pre-submissions.

Email | tifoncomp@msn.com Tel | (802) 779-4897

20190531 005146 150x150 FDA 510k Consultant TeamMatthew Walker – Human Factors Team

Matthew came to us with a regulatory background focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he was recently promoted to manage our human factors team as Branch Chief of the Human Factors Division. He is a Junior at Champlain College in Burlington, Vermont, where he specializes in Computer Forensics and Cybersecurity. Matthew participates as a member of our audit team and is passionate about risk management, human factors engineering, and cybersecurity. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts, as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.

Email | matthew@fdaestar.com Tel | +1.802.342.1446

To schedule a call with Matthew regarding auditing or human factors projects, please email him directly to schedule an appointment.

20190519 104052 150x150 FDA 510k Consultant TeamLindsey Walker – Sales Team

Lindsey Walker studied at Castleton University, way back when it was just a little old Castleton State College in Castleton, Vermont, where she received her BS in Business Marketing. She also studied at North Country Community College, where she received her Certificate in Practical Nursing. Besides preparing proposals and sending out invoices, Lindsey was recently promoted to Director of Sales. In this new position, she is responsible for managing the sales team, coordinating introductory calls with our clients, creating proposals, and managing our new billing clerk. Lindsey loves cars, but when she is not behind the wheel of one, you can find her on a pottery wheel.

Email | lindsey@medicaldeviceacademy.com Tel | (802) 989-3939

You can schedule a call with Lindsey using our Calendly app.

Alysha 150x150 FDA 510k Consultant TeamAlysha Chesser – Sales Team

Alysha (a.k.a. – Assassin Sylvia) is our social media marketing expert and gamer extraordinaire. She makes sure we deliver helpful new content every week to our blog and YouTube subscribers. She helps our team announce new live webinar training courses and the release of new and updated procedures via email. Each month Alysha also selects one procedure that will be eligible for the “Alysha” 50% discount.

Photo of Bhoomika 150x150 FDA 510k Consultant TeamBhoomika Joyappa – FDA 510k Consultant Team

Bhoomika joined Medical Device Academy as an Associate Regulatory Consultant in April 2021, and she was recently promoted to a Sr. Regulatory Consultant. She has a Master’s Degree in Biomedical/Medical Engineering from The City University of New York. Before joining Medical Device Academy, she worked as a regulatory affairs intern and completed a training program in regulatory affairs at Duke University School of Medicine. She also has previous experience as a SAS programmer and technical writer for Huawei. She is passionate about regulatory affairs, and she is making an immediate positive contribution to our clients by already completing her first few 510k submissions and developing cybersecurity checklists for our clients to help with cybersecurity documentation required by the FDA.

Email | bhoomika@fdaecopy.com Tel | (201) 290-2613

You can schedule a call with Bhoomika using our Calendly app.

Screenshot 20230107 152405 e1673123405407 150x150 FDA 510k Consultant TeamBecca Taylor – Sales Team

Becca joined Medical Device Academy as a Billing Clerk in September 2022, and she was promoted to Sales and Marketing Executive Assistant. She is working toward her Associate of Science Degree in Health Information Technology from Peirce College. Becca should be your primary contact for any billing issues, questions about proposals, help with user fee payments, help with registration and listing updates, and FDA US Agent services.

Email | becca@medicaldeviceacademy.com Tel | (253) 329-1492

%name FDA 510k Consultant TeamWonde Tekolla – FDA 510k Consultant Team

Wonde joined Medical Device Academy as an Associate Regulatory Consultant in January 2023. He has a Master’s Degree in Microbial Biotechnology from North Carolina State University and Bachelor’s Degree with a double-majored in Business Management & Health Science (with a Chemistry concentration) from Guilford College. Before joining Medical Device Academy, he worked as a quality assurance and regulatory affairs specialist for two years at Mehtra, LLC. He has prior regulatory experience with pre-submissions, 510k submission projects, and CE Marking Technical Files. He also has experience with quality system implementation for 21 CFR 820, ISO 13485, and MDSAP.

Email | wonde@fdaestar.com Tel | (919) 903-0194

You can schedule a call with Wonde using our Calendly app.

Founder & President

Rob Packard 150x150 FDA 510k Consultant TeamRob Packard

Rob is the founder and President of Medical Device Academy. He manages the FDA 510k Consulting Team. The company was incorporated in October 2013, but he wasn’t smart enough to get some full-time help until 2017. Rob is constantly doing everything to extremes. That includes Zoom meetings with Austria, Sweden, Netherlands, and Israel at 6 am; and Skype calls with China and Australia and 10 pm. He “balances” this out with two and three daily workouts and a good novel until midnight. The picture below shows Rob at the end of a training hike with his dad (77 years old at the time). I wonder where he gets his extreme personality.

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Father’s Day 2019

Email | rob@fdaestar.com Tel | (802) 258-1881

You can schedule a call with Rob using his Calendar app.

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Nonconforming Product Procedure (SYS-023) & Webinar

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This webinar bundle teaches you to excel in the skill of managing a Material Review Board (MRB) in order to control nonconforming product.

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Nonconforming Product Procedure Webinar 

This webinar will teach you how to revise, edit, and implement the procedure for control of nonconforming products (SYS-024). This procedure includes a log, form, and the procedure. It is also bundled with a training webinar that teaches you how to identify nonconforming product, segregate the nonconforming product, and manage the review of nonconforming product–including controls for disposition of nonconforming product.

MRB Ninja 1 Nonconforming Product Procedure (SYS 023) & Webinar

“Become an MRB Ninja”  MRB stands for Material Review Board which includes the following four categories:

  • Quality/Regulatory,
  • Engineering
  • Production
  • Purchasing

 Quality always needs  to approve disposition of nonconforming product and quality is responsible for the process as process owner. Production is needed if product needs rework or will be used “as is” (UAI). Engineering is also needed for rework and UAI dispositions. Purchasing is needed for return of product to suppliers. Accounting is sometimes needed for scrap of product if the dollar amount is significant (e.g., $100,000 of scrap).

When is the live webinar scheduled for the Statistical Techniques Procedure?

The live webinar is scheduled for Monday, November 4, 2024 @ 10:30 a.m. ET. If you purchased the procedure before November 4, you will receive login information to participate in the live webinar. The webinar will be hosted on Streamyard.com. If you are unable to participate in the live webinar, please send us your questions in advance so that we can be sure to address your questions in the live webinar. You will be able to download the recording from the Dropbox folder after the live webinar and you can watch it as many times as needed.

Contents Sold with the Statistical Techniques Procedure

content for SYS 0233 Nonconforming Product Procedure (SYS 023) & Webinar

Control Nonconforming Product Webinar Bundle available for $299.00:

Thumbnail or SYS 023 Nonconforming Product Procedure (SYS 023) & Webinar
SYS-023 - Control of Non-Conforming Product Procedure, Webinar & Exam Bundle
SYS-023, Control of Nonconforming Product Procedure/Forms; Become a Material Review Board (MRB) Ninja. Access to 2 live sessions (same content), native slide deck, updated procedure and exam with training certificate.
Price: $299.00

Each month Alysha picks a new procedure or webinar that will be eligible for the “Alysha” 50% discount. Just type Alysha in the discount code box. November’s discounted procedure is SYS-023 Nonconforming Product Procedure.

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. To view all available procedures click here.

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS Nonconforming Product Procedure (SYS 023) & Webinar

About Your Instructor

Rob Packard 300x260 Nonconforming Product Procedure (SYS 023) & 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 +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Instagram.

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Process Validation Procedure

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This process validation procedure (SYS-014) is designed to meet the requirements of ISO 13485:2016, Clause 7.5.6 and 21 CFR 820.75.

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Process Validation Procedure
Medical Device Academy’s process validation procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.5.6 for process validation. The procedure also addresses the requirements of 21 CFR 820.75 in the FDA QSR. Process validation is required whenever there is a process that affects product quality that cannot be 100% inspected or where inspection/testing of the medical device would be destructive. For example, sterilization processes must be validated because the sterility testing required to verify that product is sterile is destructive in nature (i.e. the product can no longer be used and is no longer sterile).

When is the live webinar scheduled for this process validation procedure bundle?

The live webinar is scheduled for Monday, October 14, 2024 @ 10:30 a.m. ET. If you purchased the procedure before October 14, you will receive login information to participate in the live webinar. The webinar will be hosted on Streamyard.com. If you are unable to participate in the live webinar, please send us your questions in advance so that we can be sure to address your questions in the live webinar. You will be able to download the recording from the Dropbox folder after the live webinar and you can watch it as many times as needed.

Scope of the Process Validation Procedure

The process validation procedure does not include software tool validation which is covered under another procedure (SYS-051) or sterilization validation which is covered in three different sterilization validation procedures:

Medical Device Academy also has a detailed sterilization validation protocol that was created specifically for EO Sterilization (i.e. PRO-001, EO Sterilization Protocol)…the page for purchasing this has not been created yet, but please contact us if you want to buy the protocol.

Process Validation Procedure Process Validation Procedure
SYS-014 Process Validation Procedure
SYS-014 Process Validation Procedure
Price: $299.00

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. 

 

Process validation steps

There are four steps in the process for process validation–not three. Most people are familiar with the acronyms IQ, OQ, and PQ. However, you need to understand the purpose of each step in the validation process–not just the acronyms. In addition, it is critical to ensure you do not skip the process risk analysis step. Not only is process risk analysis required, but any process hazards identified help you design experiments for evaluating various process risk controls to ensure that the product is consistently produced and conforming. These experiments are the core activities during the operational qualification (OQ) phase of process validation. The process validation procedure describes the IQ, OQ, and PQ phases, but process risk management is primarily found in our risk management procedure (SYS-010). The procedure does, however, state:

“Parameters requiring monitoring (e.g., minimum process capability or Cpk) shall be risk-based using documented acceptance criteria for the risk control of process monitoring.”

The video below provides an overview of each phase of the process validation cycle, and please make sure you watch the video until the end. The links provided in the YouTube video description explain where you can purchase the Medical Device Validation Handbook that Rob Packard contributed as an author.

PXL 20220422 183906233 249x300 Process Validation Procedure
Click on the book image to download the table of contents

For your convenience, a copy of the Table of Contents for the validation handbook has been added to our website and you can view it by clicking on the image of the book above. As suggested in the video below, in addition to a process validation procedure, you will also need process validation training.

To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

 

managment review sample SOP Process Validation Procedure

About the Author

Rob Packard 300x260 Process Validation Procedure

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 +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Instagram.

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Task Analysis Template & Webinar Bundle

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This human factors training webinar will teach you how to perform a task analysis to identify critical tasks for your medical device 510(k).

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Task Analysis Template & Webinar Bundle – $129

user user interface device diagram Task Analysis Template & Webinar Bundle
Task Analysis Template & Webinar Bundle
In this human factors training webinar, you will learn how to perform a task analysis as part of creating your usability engineering file. Matthew Walker and Rob Packard will be the instructors for this live webinar.
Price: $129.00

When is the Task Analysis webinar scheduled?

This webinar will be live on Thursday, October 17, 2024 @ Noon ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.

Why should you consider registering for this Task Analysis Webinar?

One of the steps in creating a usability engineering file is to perform a task analysis. Matthew Walker and Rob Packard will explain the overall process for creating a usability engineering file and how the task analysis fits into the human factors process and how it’s included in your 510k submission using the FDA eSTAR template. They will show you how to complete Medical Device Academy’s task analysis template, walk you through the new work instruction for this template, and present a few cases studies to help you understand the process. Live attendees will also be able to ask questions.

What you will receive for $129

  • Task Analysis Template
  • Login information for the live Task Analysis Webinar
  • Work instruction for performing a task analysis
  • Access to download the recording of the webinar from our Dropbox folder
  • Native slide deck for this webinar

All content deliveries will be sent via AWeber emails to confirmed subscribers.

Q&A

Please email me questions at rob@fdaestar.com regarding the task analysis webinar.

About Your Instructor

Matthew Walker Task Analysis Template & Webinar BundleMatthew Walker – QMS, Risk Management, Usability Testing, Cybersecurity

Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Systems and Regulatory Pathways. He is a Junior in George Washington University’s BSHS- Clinical Research Management Program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.

Email: Matthew@FDAeSTAR.com

Connect on Linkedin: http://www.linkedin.com/in/matthew-walker-214718101/

Rob Packard 300x260 Task Analysis Template & Webinar 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 510k 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 Instagram.

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Webinars Coming Soon

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Below is the schedule for our live webinars that are coming soon, and we have a countdown clock for our next live-streaming YouTube video.

Do you have suggestions for future webinars? Visit our Suggestion Portal.

Our latest YouTube shorts.

Weekly Live-Streaming Topics on YouTube

Below is a countdown clock for our next live-stream YouTube video and the schedule for the new live webinars we are hosting. Our next YouTube Live-streaming video will be on Friday @ 12:30 pm ET (November 8, 2024). The next live-streaming YouTube video will discuss “Quick conversion of your uFMEA to a URRA”

demand Webinars Coming Soon

Human Factors Webinars

Risk Management

Design Controls

Quality System Webinars

Auditing

MISC Webinars

CE Marking Webinars

Canadian Medical Device Licensing

If you want to be notified of new webinars another way, including the paid webinars that we do not post on our YouTube channel, please subscribe to our email webinar notification list using the form below:

 

In addition to the webinars available for purchase on this page, you can also watch videos that we have posted on our YouTube channel. If you are a channel subscriber, you will receive automatic notifications of new YouTube postings on our channel by clicking on the notification bell. The time remaining until our YouTube live-streaming video is shown below, and please don’t forget to email Rob your questions at rob@13485cert.com.

The following is a list of quality and regulatory training webinars that are available for on-demand purchase from this website. If you subscribe to our email notification list using the form on the right, we will notify you by email of any new webinars when we add them to this page. You can also suggest new topics by submitting your idea to the Suggestion Portal.

Don’t forget to subscribe to our YouTube Channel

 

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Small Business Qualification

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This page includes the information you need for small business qualification (a.k.a., SBD) to obtain a 75% FDA User Fee discount.

FY 2025 510k User Fees 1024x255 Small Business Qualification

Many small businesses don’t yet earn revenues, but if you plan to submit a 510k, you might want to file your taxes–even if you don’t need to. The new FDA user fees have been released, and if your small business has a tax return, you can qualify for a 75% discount if you submit your small business qualification application. Now in FY 2025, you can now submit your small business qualification documents to the FDA as an eSubmission through the FDA CCP to obtain a small business determination (SBD).

FDA CCP Create a Small Business Determination SBD Request 1024x247 Small Business Qualification

Note: The above dollar amounts are effective from October 1, 2024, to September 30, 2025. The full list of FDA User Fees for FY 2025 are provided on our homepage.

Application Form for Small Business Qualification

The small business qualification must be renewed each year. Most small businesses we work with fail to submit the form early enough to take advantage of this deduction, or the companies have difficulty gathering the tax records required for the application. You can download the applicable forms and guidance from our website using the links provided below:

You will need your organization ID # to complete the application form. Below is a YouTube video that explains how to obtain your organizational ID #. If your firm is outside the USA, you will also need a DUNS #.

How do you submit the small business application?

Now in FY 2025, you can submit your small business qualification documents for small business determination (SBD) as an eSubmission via the FDA CCP. Before FY 2025, all small business qualification applications had to be submitted as an original hardcopy to the FDA. If you are unable to use the CDRH portal, the physical address is provided below:

Old paper submission of small business qualification Small Business Qualification

FY 2025 began on October 1, 2024. If you plan to submit a 510k after September 30, 2025, you must wait until August 1, 2025, because that is the earliest you can apply for FY 2026 small business determination (SBD). The FDA target is to process your request within 60 calendar days, but the turnaround time has been improving at the FDA.

Payment Methods for the FDA User Fees

Once you receive the small business qualification (i.e., the SBD identification number) via email, you must enter your User Fee Account (i.e., DFUF) to create FDA Form 3601 to include it in Section 1 of the 510k submission. Form FDA 3601 is also submitted along with the physical payment of the user fee, or the company must pay the fee electronically.

Do you have questions about small business qualification?

If you have questions about small business qualification, please schedule a call with Lindsey Walker, our Director of Sales.

Call Lindsey 300x55 Small Business Qualification

Does small business qualification apply to the Establishment Registration User Fee?

The above question is very popular, but the answer is no. Regardless of the size of your company or the number of products you distribute, there is only one fee for each establishment to be registered with the FDA. If you would like assistance with registering and listing your company, you can schedule an appointment with Medical Device Academy to help you with this. We have a blog post to help you if you want to do it yourself. We also offer US Agent services for companies located outside the USA.

Additional 510k Resources

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

Screenshot from webinar 150x150 Small Business Qualification

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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Reprocessing Devices – FDA eSTAR Webinar

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In this FDA eSTAR webinar, you will learn how to prepare the verification and validation testing required for reprocessing devices.

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Reprocessing devices webinar – $79

Reprocessing Devices Thumbnail Reprocessing Devices FDA eSTAR Webinar
Reprocessing Devices - FDA eSTAR Webinar
In this FDA eSTAR webinar, you will learn how to prepare the verification and validation testing required for reprocessing devices that are identified as reusable. Training content includes the FDA guidance documents, standards for reprocessing devices, and how to develop reprocessing instructions. This webinar will be live on Thursday, October 3, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
Price: $79.00

When is the reprocessing devices webinar scheduled?

This webinar was recorded on Saturday, October 5, 2024. You can purchase it on-demand and watch the training as often as you wish.

Why should you consider registering for the webinar on reprocessing devices?

The reprocessing section of the submission is not just a paragraph referencing the recognized standards that were applied. Reprocessing devices requires design verification testing, usually costing tens of thousands of dollars. The critical factors that determine the cost of validating your reprocessing steps are:

  1. types of “soil” being simulated
  2. cleaning methods (manual, automated washing, or both)
  3. level of disinfection (none, low, moderate, or high-level disinfection)
  4. methods used to verify the effectiveness of cleaning and disinfection
  5. sterilization method (none, steam, EO, or VHP)
  6. the number of cycles being validated

All reprocessed devices require cleaning instructions to be included in the user manual or instructions for use, but those cleaning methods need to be validated. If disinfection is required, then the level of disinfection needs to be justified and validated. Finally, the sterilization method(s) need to be validated.

Hospitals that purchase your device will make sure that the methods prescribed in your instructions align with the capabilities of their sterile processing department. Therefore, most companies want to validate their device for multiple cleaning, disinfection, and sterilization methods. However, every method you validate will increase your up-front costs. For this reason, most companies limit their validation to the most widely used methods.

Another consideration is whether your methods of reprocessing devices require human factors validation. Companies usually copy standardized methods from a competitor’s instruction for use or another reprocessed device in their portfolio. Unfortunately, you never know where those instructions came from and if they were validated. Therefore, the best practice is to work with an institution that teaches sterile processing. The instructor will be able to identify problematic aspects of your device design and recommend instructions for reprocessing. Once you finalize your instructions, the same instructors can help you with summative usability testing for reprocessing your device.

What you will receive for $79

  • a recording of the webinar you can replay anytime
  • the native slide deck for the reprocessing devices webinar
  • a copy of the FDA guidance for reprocessing medical devices

The presentation includes 27 slides and was ~35 minutes long. All content deliveries will be sent via AWeber emails to confirmed subscribers.

Q&A

Please email me questions at rob@fdaestar.com regarding the reprocessing devices webinar.

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 Your Instructor

Winter in VT 2024 150x150 Reprocessing Devices FDA eSTAR 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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VHP Sterilization Validation Procedure (SYS-054)

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VHP Sterilization is vaporized hydrogen peroxide sterilization. It is a low-temperature, gaseous sterilization method.

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What is the VHP Sterilization Validation Procedure (SYS-054)?

VHP Sterilization is vaporized hydrogen peroxide sterilization. It is a low-temperature, gaseous sterilization method similar to EO Sterilization. The primary difference is that hydrogen peroxide is much safer. This procedure defines the process for validating this sterilization method in accordance with the international standard and FDA sterilization validation guidance.

VHP Sterilization thumbnail VHP Sterilization Validation Procedure (SYS 054)
SYS-054 VHP Sterilization Validation Procedure
VHP Sterilization is vaporized hydrogen peroxide sterilization. It is a low-temperature, gaseous sterilization method similar to EO Sterilization. The primary difference is that hydrogen peroxide is much safer. This procedure defines the process for validating this sterilization method in accordance with the international standard and FDA sterilization validation guidance.
Price: $299.00

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 live webinar scheduled for this procedure bundle?

The live webinar was scheduled for Monday, October 7, 2024. If you purchased the procedure before October 7, you received login information to participate in the live webinar. The webinar was be hosted on Streamyard.com. If you were unable to participate in the live webinar, please send us your questions. You will be able to download the recording from the Dropbox folder after the live webinar and you can watch it as many times as needed.

What do you get when you purchase the VHP Sterilization Procedure?

VHP Sterilization Folder 1 VHP Sterilization Validation Procedure (SYS 054)

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

managment review sample SOP VHP Sterilization Validation Procedure (SYS 054)

About Your Instructor

Screenshot from webinar 150x150 VHP Sterilization Validation Procedure (SYS 054)

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 +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Instagram.

VHP Sterilization Validation Procedure (SYS-054) Read More »

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