Richard A. Vincins, BS, CMDA, CQA, RAC-Devices, M-TOPRA, CQP MCQI

Richard Vincins has been in the industry for 30+ years, focused on medical devices specifically in these therapeutic areas: catheter technology for numerous clinical applications, laser medical devices for surgical and aesthetic procedures, software applications for digital health and In-Vitro Diagnostic (IVD) medical devices.

1. Achieved 510(k) clearance several times in less than 60 days for Class II products through US FDA
2. Implemented a full Quality Management System for ISO 13485 certification in less than 9 months for Class II electromechanical product
3. Updated and submitted Class IIb medical device Technical Documentation for EU MDR 2017/745 compliance obtaining approval in less than 6 months

His previous roles have been in quality engineering, quality assurance, compliance, regulatory affairs and clinical development support. Prior to joining NAMSA, Richard held positions with Emergo Consulting, bioMerieux, Lumenis, Medtronic and C.R. Bard. He’s spent the last 15 years in consulting, spanning multiple companies and medical device types. In his role as Vice President of Quality Assurance Consulting at Emergo, he compiled and submitted numerous 510(k) applications for US FDA, supported IDE and clinical applications, generated Technical Documentation for EU MDD/EU MDR, and provided technical writing services for clinical evaluations, biological evaluations and risk management files. His role in leading consultants and teams led to the clearance and approval of new, novel medical devices in the U.S., Europe, Canada and other markets around the world.

Richard holds several industry certificates and memberships, including: Certificate Medical Device Auditor through ASQ (CDMA), Certificate Quality Auditor through ASQ (CQA), Regulatory Affairs Certified – Medical Devices through RAPS (RAC-Devices), Member TOPRA (M-TOPRA) and Certified Quality Professional through Member CQI [Chartered Quality Institute] (CQP MCQI).

CORE COMPETENCIES

• Progressive roles in quality and regulatory through medium-sized to corporate-level organizations managing teams of individuals for quality compliance and regulatory submissions of new products
• Managing numerous regulatory strategy project plans for new, novel medical devices to understand regulatory classification
• Generating, supporting and submitting 510(k) applications for products ranging from general surgery, laser devices, IVF, implants and software only (SaMD)
• Managing regulatory submission activities with US FDA including Q-Submission requests and meetings, IDE application, IDE supplements and compiling annual reporting
• Working with clients on higher-risk, new and novel technology medical devices and IVDs with submission through the FDA De Novo process, determining benefit/risk for new medical devices, PMA applications and PMA Supplements
• Responsible for updating and revising various medical device type Technical Documentation files for EU MDR transition including technical information, clinical evaluation biological evaluation, risk management and labelling
• Participating in design and development teams for new product introduction of catheters, electronic and software-driven products, implant devices, active implant devices, software-only applications, digital health solutions, combination products and Companion Diagnostics (CDx) concerning regulatory strategy, compliance and submission content
• Conducting quality management system audits including internal audits, compliance audits, supplier audits and due diligence audits for US FDA inspections, Notified Body audits and MDSAP audits to applicable regulatory requirements
• Developing and delivering various training content ranging in topics from regulatory requirements, FDA compliance, EU MDR/IVDR requirements, quality system tools, corrective action analysis and statistical techniques
• Thorough and expert understanding of U.S. FDA regulations, U.S. FDA submission requirements, ISO 13485, ISO 9001, MDSAP, EU Medical Device Regulations (MDR/IVDR), Health Canada regulation, ISO 14971, IEC 62304, IEC 62366, various other country regulations and international recognized standards

RECENT PROJECTS

• Developed a regulatory strategy and way to market for new technology and expanded indications for use related to endoscope cleaning equipment, sterile surgical environment enclosure, hearing aid connectivity, tumour identification software applications and CDx for a cancer monitoring IVD medical device
• Managed pre-launch regulatory activities of a software-only application intended for identification, classification and characterization of tumours (U.S. target market)
  • Prepared for Q-Submission meeting for clinical and performance requirements
  • Assisted with software documentation requirements and completed successful 510(k) submission
• Led EU MDR transition project team for client updating Technical Documentation content, numerous clinical evaluation files (clinical planning and reporting), biological evaluation files, General Safety and Performance Requirements, risk management and quality system requirements (updating procedures)
• Served as a regulatory lead for introducing an aesthetic combination product to the US and European markets
  • Compiled planned regulatory strategy and technical submission content
  • Reviewed marketing literature, indications for use, QMS support and technical documentation to ensure proper classification and approval for markets

PUBLICATIONS

• “Current Good Manufacturing Practices and Quality System Design.” Chapter 5; Fundamentals of Medical Devices, Fifth Edition, Regulatory Affairs Professional Society
• “Current Good Manufacturing Practices and Quality System Design.” Chapter 8; Fundamentals of US Regulatory Affairs, Eleventh Edition, Regulatory Affairs Professional Society
• “Combination Products.” Chapter 40; Fundamentals of EU Regulatory Affairs, Eight Edition, Regulatory Affairs Professional Society
• Vincins R. “Managing Regulatory Intelligence for Medical Devices.” Regulatory Focus. January 2019. Regulatory Affairs Professional Society
• “Health Technology Assessment.” Chapter 7; Fundamentals of US Regulatory Affairs, Ninth Edition, Regulatory Affairs Professional Society