Episode 12: The Relationship among Risk Management, Clinical Evidence and Post Market Reports

The RA QA Café

Join us as we welcome two esteemed members of NAMSA’s Medical Writing team, Dr. Beatriz Rodriguez Grande and Dr. Sean Bird, for an insightful conversation on the intricate relationship between Risk Management, Clinical Evidence and Post-Market reports.

Dr. Beatriz Rodriguez Grande, who began her career in the medical device industry as a Preclinical Research Scientist in 2010, joined NAMSA via AKRN Scientific Consulting in 2021. She now leads as Team Leader for Medical Writing Services and Manager Consulting GTC. Dr. Sean Bird started his career at Cook Medical as a Regulatory Scientist in 2012 and transitioned to NAMSA in 2021, where he serves as a Principal Medical Writer. Together, they bring a wealth of knowledge on the regulatory requirements of medical writing in our industry.

Throughout our conversation, we examine the information shared among risk management, clinical evidence and post-market surveillance. We also share strategies for maintaining consistent messaging and emphasize the importance of making sure your reports properly document your product’s requirements and how those requirements are met.

“… know when you will be able to integrate the information in an efficient way so that you don't duplicate efforts.” – Dr. Beatriz Rodriguez Grande

“The CER is supporting the presence on the European market, European Healthcare is the government, right? So, what is the benefit of this device? Why is this company or country paying for the device, what is the benefit?” – Dr. Sean Bird

Discussion topics include:

• Tailoring your documentation to your targeted audience
• Coordinating information and actions
• Benefit/risk strategies
• Setting the bar and demonstrating you’ve met it through data-backed evidence

Links:

Clinical Data Requirements Under MDR: A Panel Discussion | NAMSA