Vincent has been with NAMSA for 18 years and has held a variety of laboratory, operations, business development and consulting roles during that time. He currently leads the Global Product Development, Reimbursement Strategy and Project Management teams.

 CORE COMPETENCIES

• Providing multiple consulting services to manufacturers with sterilization validation projects (i.e., strategy design, Instruction for Use [IFU] reviewing, writing protocols) for both single-use and reusable devices to submit to the U.S. Food and Drug Administration (FDA) and/or for CE-mark applications
• Delivering multiple on-site consultancy sessions to manufacturers on biocompatibility and sterilization validation issues to comply with ISO 13485, EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR) 2017/745, FDA, Pharmaceuticals and Medical Devices Agency (PMDA) and National Medical Products Administration (NMPA) requirements
• Creating multiple biological risk assessments on several devices, supporting CE, FDA, China Food and Drug Administration (CFDA) and PMDA registrations
• Leading and contributing to the development of several Medical Device Development Plans through the 6 phases approach (Concept, Design Planning & Development, Design Verification, Design Validation, Process Validation & Commercialization, Post-Market Activities)
• Serving as a distinguished speaker at multiple international conferences focused on biocompatibility, biological risk assessment, Clinical Evaluation Reports (CERs) (MEDDEV 2.7/1) and EU MDR 2017/745 (ex., MEDTEC, CIMDR, Q1 events)
• Preparing and reviewing several Summary of Technical Documentation (STED) records according to EU MDD 93/42 amended 2007 and/or Global Harmonization Task Force (GHTF) guidance document, “SG1-N41R9:2005 Essential Principles of Safety & Performance of Medical Devices”
• Providing on-site training to manufacturers on CERs through literature search to comply with European Authorities requirements (MEDDEV 2.7/1)
• Preparing several CERs, De Novo applications and updates for EU manufacturers in orthopedic and spine areas
• Supporting remediation efforts for CE-marking maintenance and ISO 13485 certificate maintenance under EU MDR 2017/745
• Conducting several training and consulting services for manufacturers on risk management according to EN ISO 14971
• Delivering training and consulting services to manufacturers on quality systems according to EN ISO 13485