Medical Device Consulting for QuickER FDA Approval

Add a 15 year FDA veteran to your regulatory team today

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ABOUT FELLMAN DEVICE GROUP

Led by a highly accomplished 15-year veteran of FDA, Fellman Device Group provides personalized consulting services to quickly get your medical device from concept to FDA clearance or approval.

We apply our intricate knowledge of FDA pre-market and post-market submissions, complex medical devices, policies, initiatives, guidances, new programs, and staff under CDRH’s reorganized OPEQ structure to help you navigate the FDA process. We leverage extensive experience with FDA/industry written interactions and meetings leading to resolution of complex technical and regulatory issues to guide you to efficient and successful FDA review and approval of marketing submissions and investigational clinical studies.

Diverse Device Experience

Cardiovascular Devices
General Surgery Devices
Other Medical Devices

Extensive Regulatory Expertise

FDA Programs
New Technologies
Testing and Clinical Studies
Fellman Device Group Medical Device Consulting

Why Hire FDG

As a small independent medical device consulting firm, Fellman Device Group provides personalized service to exactly fill any expertise or role you are lacking. Our direct and recent FDA experience including knowledge of the FDA staff in the different device OHTs, knowledge of new programs, and diversity of skills (from review of engineering tests to high level regulatory strategies) separates FDG from larger consulting firms.

Would you benefit from…

  • Having a recent FDA branch chief pick up the phone every time you call with a question?
  • Advice from a recent FDA reviewer regarding your bench, in-vivo, or clinical studies?
  • Help developing a successful strategy for a Breakthrough Device request?
  • An expert “translation” of FDA feedback to aid your response?
  • A regulatory assessment for your novel device concept?
  • Adding an experienced regulatory advisor to your team?
  • Assistance preparing high quality regulatory submissions?

LET FELLMAN DEVICE GROUP HELP YOU PREPARE YOUR SUBMISSIONS TO GET EFFICIENT FDA REVIEWS AND TIMELY FDA APPROVALS

Adding an FDA veteran branch chief and reviewer to your team can make all the difference to assure that you have a viable regulatory strategy in place, conduct the proper testing for your device, and prepare organized submissions that are efficiently reviewed and approved by FDA.