About Us

Medical Device Consultation

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.

Mark Fellman - Fellman Device Group

Mark Fellman

Medical Device Regulatory Affairs Consultant
Mr. Fellman is a highly skilled biomedical engineer and FDA regulatory expert with unusually diverse experience in complex medical device technology and FDA regulations. During his 15-year career at FDA he served as a reviewer, team lead, branch chief, deputy director, and Director within the CDRH Office of Device Evaluation (now OPEQ). Fellman Device Group was established to provide personalized and focused regulatory services to medical device manufacturers, entrepreneurs, and technology investors. Mr. Fellman’s knowledge of FDA staff, FDA programs, FDA regulations, and complex FDA interactions can help you navigate the FDA process to get your devices efficiently to the US market.