Effective Communication with Notified Bodies

In this episode of NAMSA’s RAQA Café Podcast, we are excited to welcome back two esteemed members of the NAMSA team—Paul Risborough, B-Eng (Hons) (Principal Regulatory Consultant) and Matt Royle, PhD (Principal Regulatory Consultant)—to discuss critical aspects of effectively communicating with Notified Bodies.

Both Paul and Matt bring a wealth of experience to the table, having previously worked for Notified Bodies themselves. They have since leveraged their insider knowledge to aid numerous NAMSA clients in navigating the nuanced interaction process with their respective reviewers.

“You know the review system should be you get first round of questions to answer. If you get a second round it’s because you know you didn’t answer the first round properly.” –  Paul Risborough

Discussion topics include:

• Communication between manufacturers and Notified Bodies
• Reviewing and responding to reviewer questions
• Maintaining good relationships
• Dispute resolutions

*Please note that the opinions discussed throughout the podcast are their own and do not reflect those 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 BSI manager, Paul was an Active and Active Implantable Device Technical Specialist, Scheme Manager, and an 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 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.