Effective Communication with your Notified Body

The RA QA Café

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 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 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 the 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