Risk Management, Clinical Evidence and Post-Market Reporting

RAQA Café

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

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

*Please note that the opinions discussed throughout the podcast are their own and do not reflect those of their current or former employers.

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.

Beatriz Rodriguez Grande, PhD

With a background in Neuroscience research, Beatriz started working in industry in 2019, within medical affairs in a pharmaceutical company. In 2021 she joined a medical device consulting company, where she worked as Regulatory Affairs Manager, supporting the development of a team trained in the European Medical Device Regulation 2017/745 (MDR). Beatriz joined NAMSA in 2023, where she leads a group of medical writers mainly focused on clinical evaluations and is a teacher at several local University Master´s programs. Beatriz has helped clients on MDR adoption through strategic consulting and development of clinical evaluations, MDD to MDR gap assessments, literature reviews, SSCPs, post-market documentation and other technical documentation. She has worked closely with the clinical department to provide solutions for meeting the requirements for obtaining a CE-mark for a diversity of manufacturers, from start-ups to multinational companies, and with a variety of products, from well-established technologies to innovative devices at various stages of development.

Sean Bird, BS, PhD

Sean started as a Regulatory Scientist in the medical device sector, focusing on intravascular devices. He transitioned to Technical Writing, crafting Clinical Evaluation Reports and Summaries of Safety and Clinical Performance for a global company. In 2021, Sean joined NAMSA, working on CERs aligned with European regulations MDD and MDR. At NAMSA, he manages a team of US medical writers. With experience across various medical device classes and therapeutic areas, Sean has extensive industry knowledge. His academic background includes a BS in chemistry from Purdue University and a PhD in analytical chemistry from Indiana University. He’s also a member of Regulatory Affairs Professionals Society (RAPS).

Risk Management, Clinical Evidence and Post-Market Reporting

Published:

RAQA Café

Richard M. Granquist

Beatriz Rodriguez Grande, PhD

Sean Bird, BS, PhD

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