Jason Gromek

Jason Gromek is an experienced Quality Consultant and Product Commercialization individual in the medical device industry. With a background in Management, Device Design, Quality Management Systems, Regulatory Submissions, and Regulated Industry compliance, Jason is a knowledgeable leader in FDA Warning Letter and 483 remediation teams. He possesses a deep understanding of Design Controls (21 CFR 820.30), CAPA systems, Software validation (21 CFR 11), Risk Management (ISO 14971), and Medical Device Electrical Safety standards (IEC 60601) among others. Jason's expertise extends to Software development (IEC 62304) and Arena PLM. Jason studied at The University of Akron and Lakeland Community College. His professional experience includes roles such as President/Medical Device Consultant at BioDevice Design, Former Partner and Senior Director at MEDIcept Inc., Former Senior Quality Assurance Consultant at MEDIcept Inc., Former Director of Engineering and Development at Meditech Spine, LLC, Former Project Manager/Senior Designer at O'Savage BioMechanics, Inc., and Former Project Manager at DAD Engineering Group.