Jason Gromek

Jason Gromek is President and CEO of MEDIcept, bringing more than 20 years of leadership experience in medical device design, regulatory strategy, and quality systems. He has spent more than a decade with MEDIcept, helping medical device, diagnostic, and combination product companies navigate product development, FDA requirements, remediation, and commercialization with greater clarity and confidence. Before becoming CEO, Jason led MEDIcept’s Sales, Quality, Regulatory, and Clinical teams as Executive Vice President of Sales and Operations. His expertise spans FDA Warning Letter and 483 remediation, Design Controls, CAPA, software validation, risk management, and ISO 13485-compliant Quality Management Systems. Prior to MEDIcept, Jason founded BioDevice Design, LLC and held leadership and consulting roles in medical device development, including work supporting regulatory clearance for spinal implant technologies. He is a Certified Biomedical Auditor, Certified Quality Auditor, and member of the American Society for Quality.