About Our Team
MEDIcept is an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For three decades, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Clinical Research Organization (CRO), Regulatory Affairs, Quality Management System, Quality/Software Engineering, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs.
Our Mission
MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions.
Our Values
MEDIcept's relationships are built on integrity and communication to provide customized innovative and quality solutions in a collaborative manner.
Our Team
Board Members
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.
F. David Rothkopf
Founder
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.
Jason Gromek
President and CEO
Brian Markham
Chief Quality Officer
Brian has over 30 years of medical device and quality management systems experience. He provides audit readiness training and consultation for our clients. His expertise includes providing quality leadership for organizations undergoing significant quality system changes due to regulatory concerns, remediation, acquisition, or growth. His career began as a bench chemist developing diagnostic ELISA kits. Career experience was gained through product support, development, facility compliance, and corporate level quality assurance roles.
As Chief Quality Officer, Brian assists clients start to finish through the regulatory inspection process. This includes preparation, management of interactions, response to findings, and implementation of corrective and preventive actions (CAPAs). He assists clients in responding to FDA 483 observations, Warning Letters, and Consent Decrees, ensuring timely and effective remediation plans. Prior to merging with MEDIcept in 2020, he owned and operated Quality Systems in Motion, Inc. (QSIM), providing expert consultation resources to medical device, biotech, and pharmaceutical organizations facing challenging compliance concerns. Brian has served in quality leadership positions at both small and large organizations, including Bayer, Boston Scientific and Abbott Bioresearch.
He holds a bachelor’s degree in Chemistry from Virginia Tech and an associate’s degree in Mathematics from Bergen Community College.
Brian Markham
Chief Quality Officer
Executive TEam
Celeste Grant
Vice President, Global Clinical and CRO Services
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.
Carolyn Russell
Vice President, Technical Services QARA
Lisa Wagner
Vice President, Human Resources
Lisa is an accomplished Human Resources professional holding a Senior Professional Human Resources (SPHR) certification with over 25 years of experience leading human resources operations and organizational planning. Lisa is well-versed in employment law, performance appraisals, salary structure, and benefits program management. She is a seasoned expert at protecting company interests and building a successful company culture, promoting employee retention and performance.
As the Vice President of Human Resources at MEDIcept, Lisa is an integral part of the executive management team, driving the development of creative strategies to support rapid business growth with a focus on the mission, vision, and values of MEDIcept.
Before joining MEDIcept in 2021, Lisa was the Director of Human Resources for Canyon Ranch in Lenox, Massachusetts, and Starwood Hotels & Resorts Worldwide, Inc. With nearly 30 years of hospitality experience, Lisa understands the importance of communication and employee engagement.
Attending both Mount Ida College and Cornell School of Industrial & Labor Relations, Lisa has a passion for Human Resources and continuous learning. She holds both a PHR & SPHR certification and a certification in Human Resources Studies through Cornell. Lisa is a member of many human resources organizations and has previously held a seat on the Board of Directors for the Hospitality Human Resources Association of Arizona and the Berkshire Country Regional Employment Board.
Lisa Wagner
Vice President, Human Resources