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