Barry is a biomedical engineer with a chemical engineering concentration. He is president/founder of RQMIS Inc. a consulting company with experience in the Medical Device/Biotechnology Industry focused on Regulatory/Clinical/Quality Affairs and Product Management. RQMIS Inc. provides support in the areas of regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDA QSR and ISO 13485) and FDA Negotiation and Communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls). Barry has seven years’ experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District. This government experience was followed with seventeen (17) years in midlevel and executive management positions in small start‐up and large multinational medical device companies. Market responsibilities included United States (including Puerto Rico), European Union, South America, Canada, Japan and South Korea. Barry has provided companies with regulatory and clinical strategic advice on bringing novel technologies to the United States and EU markets in the clinical fields of orthopaedics/neurosurgery/diabetic care (spine, restorative/reconstructive, sports medicine and wound healing), gastroenterology/urology/ gynecology/pulmonology/ cardiology/plastic surgery (endoscopy/laparoscopy/minimally invasive/biliary stents). The devices involved have included active implantables, Human Tissue/ATMP, long‐term implants, electromechanical, ultrasonic imaging and PACS products. Regulatory and clinical strategic guidance regarding product intended use, marketing claims, and publications has been provided to assure ongoing compliance with FDA clearances/approvals of medical device, biologics, tissue and drugs.