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

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Mary Vater, Consulting Partner

%name Contact us for help with your FDA 510k or De Novo submissionMary is a biomedical engineer and consultant with Medical Device Academy. She recently celebrated her 7th anniversary with our firm, and she was promoted to consulting partner. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices, artificial intelligence, and Software as a Medical Device (SaMD). She also has experience with FDA De Novo Classification Requests, CE Marking, and Canadian Licensing applications. She served as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.

Email | mary@fdaestar.com Tel | (913) 274-9899

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

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