F. David Rothkopf has more than 30 years of professional strategic experience in the development and regulatory control of medical devices. He is the President and Co-Founding Principal at MEDIcept; established in 1996 to offer engineering, manufacturing, quality, and regulatory consulting assistance to the medical device and IVD industry. David’s expertise includes technical and hands-on knowledge in a variety of regulatory, management, and quality processes. He has performed well over 400 ISO 13485 and FDA-style audits. MEDIcept and he have worked on over 450 510ks, PMAs and Technical Files. He has trained many medical companies and the FDA on the intricacies of Design Control, risk management and hazard mitigation throughout a product life cycle. He has taught classes at RAPS, ASQ, and SQA annual meetings. In addition to being President of MEDIcept Inc., David is President of SON Medical, a medical software consulting firm and has been instrumental in starting three medical device companies. Mr. Rothkopf holds both a Bachelor and Master of Mechanical Engineering degree from WPI in Massachusetts and an MBA from Boston University.Specialties: Medical Device FDA Submission, Design Control, Risk Management, Documentation development