Medical Device 510k submissions, quality systems and training

Are you a start-up device company that needs help preparing a medical device 510k submission, quality system and training?

Who is Medical Device Academy, and who is our ideal consulting client?

We are a full-service, quality system and regulatory consulting firm for medical device companies. The name “academy” emphasizes our love for training. We specialize in helping entrepreneurs get their first product to market–regardless of whether that is in the USA, Europe or Canada. Ideally, you are located in another country, and you need help understanding the requirements of the US FDA. The best time for you to contact us is at the early stages when you have an proof-of-concept prototype, but you’re not sure what to do next. You also might be under-capitalized, and you need advice on how much to budget and how to use your limited funding most efficiently.

Where is our consulting firm located?

Nearly 100% of our consulting work is remote–unless we are conducting an internal audit or a supplier audit for you. Mary Vater lives in Kansas, but the rest of the consulting team lives in the mountains of Vermont.

What do our quality and regulatory consultants do?

Most of our work is preparing regulatory submissions, but 20% of our work is involves helping you implement your quality system. We can help you with your medical device regulatory submissions. We specialize in medical device 510k submissions, preparation of CE Marking Technical Files and Canadian device license submissions. We also created a new business unit that specializes in preparing, printing, validating and shipping FDA eCopies for pre-submissions, 510(k) submissions and De Novo requests. Most of our clients are small and mid-size medical device companies that need continuing education training, and quality System Auditing for compliance. Clients that have urgent needs where time to market is critical, turn to us. Our passion is teaching medical device professionals how to prepare for future regulations and self-monitor compliance, so that they can avoid compliance remediation. Click on the download button for a description of our consulting services and our standard pricing sheet.

How are we different from other quality and regulatory consultants?

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

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

We could tell you what you want to hear, but the truth is you can only estimate the time to obtain medical device 510k clearance by analyzing the data from recent, previous submissions for the same product classification. Even classification is different, and the average ranges from less than 90 days to almost 180 days. Overall, the average is 125 days. We can explain the options for abbreviated 510(k) submissions and third-party reviewers, but in general the biggest delays are caused by the need to repeat testing because clients skipped a pre-submission meeting.

What do we charge for preparing a medical device 510k submission?

We charge $14,000 for a flat-fee–including the cost of the pre-submission (even if you don’t want one). We provide a little more details about this recent pricing increase and FDA user fees for FY 2020 in a recent blog posting. A link for downloading our standard pricing sheet for all services is provided below.

Download Button 300x93 Medical Device 510k submissions, quality systems and training

FDA eCopy print and ship services for FDA submissions

FDA eCopies are not included in our flat-fee pricing, because it is a separate service that we offer to other consultants and clients alike. At one time we charged a per-page printing fee, and a flat-fee for validating and shipping your eCopy. However, in 2018 the FDA changed its eCopy policy. Now, only a cover letter must be printed, rather than the entire submission. Therefore, we now charge a flat-fee of $150/eCopy to everyone. If you want our help reviewing your submission, or correcting problems with creation of an eCopy, we charge hourly consulting fees to help you get your submission received and accepted by the FDA. We frequently ship two (2) eCopies in the same day, and there are four (4) of us that can validate and ship your eCopy–even if we didn’t prepare the submission.

Turn-key quality system implementation

We have been writing procedures since 2003, and Rob Packard was the certification auditor for more than 100 different device companies. We have a complete set of procedures for compliance with US, European and Canadian device regulations. If you are a start-up, we can provide you with a complete set of procedures for your quality system as quickly as you can approve them. We also provide training webinars for all of the key elements of your quality system. Most important of all, we provide weekly, 30-minute calls to answer your questions and to make sure you quality system implementation is proceeding smoothly. We also offer to record these sessions so you can have customized training that addresses your specific needs. Our flat-fee for the turn-key quality system is $7,500, but about a third of that fee covers 16 weekly calls during the quality system implementation. You can also purchase our procedures individually if you already have a quality system.

Is our flat-fee pricing all inclusive?

No. Pricing is intended to cover our consulting time. Regulatory submissions typically have a fee, ISO certification has fees and our flat-fees do not include certain consulting, such as internal audits, supplier audits, or helping you conduct design reviews. To download our standard pricing and services information sheet, click on the download button above.

FDA small business qualification for FDA submissions

The FDA user fees for 513(g) submissions, 510(k) submissions and De Novo requests are all discounted for qualified small businesses. In order to qualify, you must submit a qualification form (FDA Form 3602 or 3602A) each new fiscal year (October 1 – September 30). We recommend that every company submit on August 1 for the next fiscal year–even if they are not sure if they will submit. This advice alone will save your firm thousands of dollars. Below is a table listing all of the FDA user fees for submissions–both standard and small business fees.

FDA User Fees 2020 Medical Device 510k submissions, quality systems and training

Medical device product classifications and regulatory pathways

The FDA regulatory pathway, and other regulatory pathways, is dependent upon the classification of the device. We offer a flat-fee, regulatory pathway analysis: $750 for USA, $500 for Europe, and $250 for Canada. We also help you determine the testing requirements, identify potential predicates, and we explain the quality system requirements for your type of device. This is typically included in our flat-fee for a 510(k) or De Novo Request, but if you chose this service, we will give you a credit in a subsequent 510(k) or De Novo Request.

FDA substantial equivalence (SE) decision process

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

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

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

Medical device 510k project management

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

Contacting our consulting team

Typically, clients schedule calls using our calendly app. Rob typically starts his day with calls to European clients and Western Asia around 6am, and calls with the West Coast often extend past 6pm. If you need a time that is earlier or later, please just send us an email. Our Skype and Google Voice numbers are provided in the above video as well.