RAQA Café Live! – RAPS EU Convergence and Effective MDR-Compliant Periodic Safety Update Reports

Operating room with monitor

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Audio

RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.


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.

Matt Royle

Matt Royle

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

Paul Risborough

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).

Richard M. Granquist

Richard M. Granquist

In 2014, Rich joined NAMSA as a Quality Systems Consultant and has now been with the company for eight years. Over his 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485 and ISO 15223. Rich’s medical device industry experience also includes 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 aseptic technique and terminal sterilization at Cook Medical. During his 8-year career at Cook, he expanded his responsibilities to include coordination of preclinical testing, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices.

Linford Leitch

Linford Leitch

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.