Contact us for help with your FDA 510k or De Novo submission

To answer your questions about FDA 510k submissions, FDA compliance, or training, please contact us using the calendar links below.

For a free introductory call, please contact us

If you need help with your 510k submission, De Novo submission, other regulatory submissions, continuing education training, or QMS auditing for compliance, please contact us at Medical Device Academy. We also offer eCopy validation and uploading services if you do not have your own FDA Customer Communication Portal (CCP) account. Often, we can answer simple questions at no charge, or we may be able to recommend existing products that provide exactly what you need. If your needs are more complex, we can provide a consulting proposal.

Lindsey Walker, Director of Sales

20190519 104052 150x150 Contact us for help with your FDA 510k or De Novo submissionLindsey 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 | Tel | (802) 989-3939

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Typically, medical device consulting clients schedule calls using our calendly app. Rob typically starts his day with calls to European clients and Western Asia around 6 am and calls with the West Coast often extend past 6 pm. If you cannot find time on Rob’s calendar, please schedule a call with Lindsey. She will get you the answers you need and provide you with quote or proposal for consulting work. Our Mobile/Whatsapp numbers are provided on the scheduling calls page. If you are looking for testimonials, please visit our testimonials page. 

Rob Packard, President

Winter in VT 2024 150x150 Contact us for help with your FDA 510k or De Novo submission

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

Email | Tel | (802) 258-1881

Call Rob Button 1024x185 Contact us for help with your FDA 510k or De Novo submission

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6 thoughts on “Contact us for help with your FDA 510k or De Novo submission”

    1. Updating a US Agent is relatively easy, but if you are trying to make the change between October 1 and December 31, you must first pay your user fee and renew your registration for the next fiscal year. Once you renew your registration, then you can make this change. After you renew your registration, then you can edit the US Agent. You may find that your current US Agent expects you to pay them for the new fiscal year. Therefore, you should be sure to notify the current US Agent that you will not be using their services for the next fiscal year before you renew your registration. This is a good topic for a video. I will try to create a video to show how this change is made and share it with the people that subscribed to our FDA US Agent email subscription: If you did not subscribe already, just fill in the form and confirm your subscription.

  1. Medical Device Academy’s Usability Procedure was a turnkey solution for my company. The webinar and Procedure combo covers everything we needed for implementation and training. A high level of detail with the application of “make it make sense” are wrapped in gift style with this package. “YES”…..I piled it on because it’s true. Rob and team ensured you get you money’s worth.

    1. Robert Packard

      Thank you very much Levi. Matthew and I have done a lot of work to improve the content. Stay tuned…more human factors content is coming.

  2. Rob assisted us with a DHF audit when I was head of quality for Biomimetic Therapeutics in Franklin Tn.

    I am now a consultant for the medical device /combo products industry If I can assist you with any projects please let me know.

    1. Robert Packard

      Hi Deb,

      Thank you for the comment. It’s been a minute (or more). It’s great to hear from you. We’ll definitely keep you in mind for combination projects.


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