About Our Team

F. David Rothkopf
President and Founder

F. David Rothkopf has 35 years of professional strategic experience in the development and regulatory control of medical devices. He is the Founder and on the Board of Directors of MEDIcept Inc., established in 1996, offering innovative, trusted, and cost-effective Quality, Regulatory, and Clinical solutions to the medical device and invitro diagnostic industries. His expertise includes technical and hands-on knowledge in a variety of regulatory, compliance management, and quality process. He has performed over 400 ISO 13485 and FDA-style audits in the past 20 years. David has submitted over sixty-five 510ks and PMAs. He has trained many medical companies and the FDA on the intricacies of Design Control, CAPA, Software Validation, Risk Management, and Hazard Mitigation throughout a product life cycle. 

David is an adjunct professor at MIT advising Doctoral students in Regulatory Affairs, a mentor for MassChallenge Accelerator, MIT Idea² program, NIH's NHLBI Catalyze Program, HHS’s ARPA-H Program, and now advises undergraduates at the University of Texas, Dallas and Worcester Polytechnic Institute. He is also, a shareholder advisor for four device companies and a partner in two orthopedic device companies. Before joining MEDIcept, he was the Chief of Operations and co-Founder of Zmed and Chief of Operations and co-Founder of Mrad and was instrumental in their sale. He was the Director of Quality at Uromed and a Project Leader at Johnson and Johnson Professional.

David holds a B.S and M.S degree in Mechanical Engineering from Worcester Polytechnic Institute and an MBA from Boston University. He is a member of RAPS, ASQ, ASQ Biomedical, and ASME. He is a Board Member and Treasurer for a not-for-profit special needs school.

Jason Gromek
President and CEO

Jason Gromek is an experienced executive and quality consultant with over 20 years of leadership in medical device design, regulatory compliance, and quality systems. With a deep foundation in product development, commercialization, and operational strategy, Jason has built a career helping medical device, diagnostic, and combination product companies bring innovative technologies to market efficiently and compliantly.

Jason has been with MEDIcept for over 10 years, where he has held progressive leadership roles. He has been a key contributor to the development and implementation of 21 CFR 820 and ISO 13485-compliant Quality Management Systems, leading initiatives across product development lifecycle management and both U.S. and EU regulatory guidance. His expertise spans FDA Warning Letter and 483 remediation, Design Controls (21 CFR 820.30), CAPA systems, Software Validation (21 CFR 11), Risk Management (ISO 14971), Electrical Safety (IEC 60601), Software Development (IEC 62304), and PLM systems like Arena.

Before becoming President and CEO of MEDIcept, Jason served as Executive Vice President of Sales and Operations, where he led the Sales, Quality, Regulatory, and Clinical teams. In his current role, he is responsible for setting and executing company-wide strategic direction, cultivating long-term client relationships, and promoting a collaborative, performance-driven culture.

Prior to joining MEDIcept, Jason was the Founder and President of BioDevice Design, LLC, a medical device development firm and founding member of America Makes—the National Additive Manufacturing Innovation Institute. He also held leadership roles at Meditech Spine, where he spearheaded regulatory clearance efforts for Hydroxyapatite-PEEK technology, making Meditech only the second company in the world to receive such clearance. In addition, he worked as a medical device design consultant at O’Savage Biomechanics and holds multiple patents in the field of spinal implants.

Jason is a member of the American Society for Quality (ASQ) and is a Certified Biomedical Auditor and Certified Quality Auditor. He remains passionate about building strong teams, fostering strategic partnerships, and ensuring companies have the regulatory, quality, and clinical foundations necessary to succeed in today’s dynamic healthcare landscape.

Carolyn Russell
Vice President, Technical Services, QARA

Carolyn Russell is a seasoned leader in Quality Assurance and Regulatory Affairs with over 25 years of proven success in developing and implementing quality management systems for global organizations. With a career dedicated to enhancing compliance, streamlining processes, and mentoring teams, she brings a wealth of experience. Although her focused area of expertise includes Quality and Compliance Management, QMS harmonization, remediation efforts, risk management, supplier management, CAPA, training, and document and change management, she has broad experience and in-depth knowledge of FDA and international requirements pertaining to product development, risk management, and post-market activities. In addition, she has assisted clients with Adverse Event reporting, annual reporting, UDI and FDA facility and device registrations.

As VP Technical Services – QARA, Carolyn is responsible for strategic direction and operational execution of the Quality Assurance (QA) and Regulatory Affairs (RA) services, including leading the team of QA/RA professionals while ensuring the delivery of high-quality, compliant, and efficient consulting services. In addition, she serves as a subject matter expert, providing strategic guidance to clients and internal teams on complex regulatory and quality challenges. Deep understanding of global medical device regulations, quality management systems, and successfully navigating the complexities of the medical device industry. She performs internal audits, supplier audits, assist clients with FDA investigations and ISO assessments, and deliver customized client training and education programs.

Before joining MEDIcept, she worked as a compliance leader in the medical device and manufacturing industry (SaMD, radiology, aesthetic lasers, and cardiac devices). This includes serving as Director of Quality, Senior Manager of Quality and Compliance, and Senior Quality Manager, including designation as Management Representative and US Agent for foreign business units.

Carolyn holds a B.S. degree in Business Studies, Industrial Organizational Psychology from Southern New Hampshire University. She’s a member of American Society for Quality (ASQ) and Regulatory Affairs Professional Society (RAPS) and is a Certified Quality Auditor through ASQ and holds several lead auditor certifications and a Regulatory Affairs Certificate: Medical Devices through RAPS.

Bob Silva
Vice President, Technical Services, Quality Engineering

Bob Silva has extensive experience with domestic and international medical device development as an engineering executive having managed collaborative engineering teams designed to effectively create customer focused solutions.  His background in medical device design and development started in software and expanded over the years to provide full engineering expertise in all aspects of medical device design and development.  This includes full product life cycle development from concept through design and into product manufacturing working in startup environments as well as large corporate entities.  He is a strategic thinker with the engineering leadership skills and experience in product and software lifecycle development that has resulted in approved product continuing to be used in the field today.

As the Vice President of the Quality Engineering team at MEDIcept, Bob is responsible for ensuring that day-to-day operations of the systems and software Quality Engineering department work collaboratively with other departments in MEDIcept, ensuring compliance related to systems and software design and development on the various client and MEDIcept projects.  This includes successfully planning and managing multiple, parallel projects to successful completion on time and within budget and to the satisfaction of MEDIcept customers.

Before joining MEDIcept, Bob held various leadership positions at companies like Draeger Medical System, KMC Systems, FluidNet / Ivenix, Infraredx and Transfusion Technologies / Haemonetics.  Early in his career he was responsible for the design and development of medical device software for some of these companies resulting in product still being used in industry today.  He also has experience with in the late ‘80s and early ‘90s with Symbiotics, Inc. where, as a founder, he was responsible for helping acquire venture backed funding to drive the development of an object-oriented middleware solution used to connect computers of different types together that ultimately was embedded within IBMs OS-2 operating system.

Bob holds both a B.S. and M.S. degree in Computer Science from Northeastern University.