Medical Device Consulting for QuickER FDA Approval
Add a 15 year FDA veteran to your regulatory team today
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
Extensive Regulatory Expertise
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?