Management
The MEDIcept team provides an integrated approach to every facet of medical regulatory and compliance consulting. We’ve successfully designed, developed, patented, conducted clinical trials and obtained regulatory approval for medical devices for companies around the world.
F. David Rothkopf, President and Lead Principal
With over 20 years of medical operations, quality assurance, and regulatory compliance experience, Dave has held managerial and director positions for SON Medical, MDCI, Johnson & Johnson Professional, Zmed, mRad and UroMed. He has extensive knowledge of biocompatibility, sterilization and packaging validation requirements and speaks regularly about quality and regulatory issues at national industry seminars.
Sharyn Orton PhD, Senior Consultant
Sharyn is a former FDA CBER Deputy Director at CBER and Director of Regulatory Affairs at Fenwal. She has over two dozen publications and three patents to her credit and has been principal investigator on six clinical studies. With over 30 years of regulatory, clinical, and blood application and medical device application experience, Sharyn helps guide MEDIcept clients through the regulatory submittal and compliance mazes.
Steven Woolfson,Co-Founder, Staff Engineer
Steve has over 20 years of medical mechanical engineering and Design Control experience. He has hands-on, early stage product development, due diligence, validation, DHF auditing, production process, and clinical trial experience. He has held management positions in Dyonics and venture capital financed companies including UroMed and Viacor. Steve has over 23 issued patents.
Some of our senior staff include:
- Ines Burgos, Senior Quality Consultant
- Fides Mata, Senior Quality Consultant
- Todd Rhodes, Senior Consultant
Glen Jorgensen, Co-Founder & Staff Engineer
Glen has over 30 years of experience in medical device design and involved in over 20 patents. His extensive knowledge of medical device design and manufacturing is invaluable in helping our clients successfully introduce new products.