RAQA Café Live! – RAPS EU Convergence and effective MDR-compliant Periodic Safety Update Reports

NAMSA is delighted to host the first live edition of the RAQA Café with our hosts, Linford Leitch and Richard Granquist.

While at the Regulatory Affairs Professional (RAPS) Conference in May 2023, we sat down with UK-based EU Medical Device Regulation (MDR) experts, Matt Royle and Paul Risborough, both serving as Principal Regulatory Consultant at NAMSA, to discuss:

• Highlights and takeaways from the RAPS EU Convergence Conference
• Best practices for writing effective MDR-compliant Periodic Safety Update Reports (PSURs)
• Lessons learned when documenting benefit-risk in recent projects
• And more!

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Meet the Speakers

Matt Royle, PhD; Principal Regulatory Consultant, NAMSA

Matt supports medical device clients worldwide to understand and meet the regulatory requirements in the EU. He has over 15 years’ experience in medical device research, product development and regulatory affairs. He has experience in start-ups, medium-sized and multinationals, bringing new products to market and supporting existing portfolios, and providing leading roles in advising and implementing EU regulatory strategy. He worked as a Notified Body Product Specialist for a number of years, specialising in conformity assessment of implantable class III and IIb orthopaedic joint replacement and sports medicine, spinal, and bone grafting devices, as well as associated class IIa instruments. Matt has a Master’s degree in Mechanical with Medical Engineering from University of Leeds, a PhD in orthopaedic biotriobology from Queen Mary, University of London, and is a Chartered Engineer with the Institution of Mechanical Engineers.

Paul Risborough, B-Eng (HONS); Principal Regulatory Consultant, NAMSA

Paul Risborough holds the position of Principal Regulatory Consultant at NAMSA. Until recently, Paul worked as the Global Head of Active Implantable Medical Devices at BSI, Notified Body, overseeing the Medical Device compliance of Active Implantable Medical Devices. Before becoming a Manager at BSI, Paul was an Active Implantable Device Technical Specialist, Scheme Manager and ISO 13485 Auditor. Previously, Paul worked as an electronics design engineer, project leader, and engineering manager involved in designing and manufacturing syringe pumps, large volume pumps; RF, ultrasonic, and gas plasma surgical tools; needle-free injectors, and SpO2 meters.
Paul has an education in Systems Engineering, BEng (Hons).

Linford Leitch; Former Regulatory Consultant, NAMSA

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich started in the medical device industry as a Microbiologist focusing on preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.