QMSR, ISO 13485:2016, and What It All Means for Medical Device Risk Management

The Factor, a Trusted Podcast for the Life Sciences Industry

Naveen Agarwal, PhD and Nate Blazei discuss the QMSR and the relationship to ISO 13485:2016 and how Risk Management is the cornerstone to success.

The new Quality Management System Regulation (QMSR) from the FDA represents a significant shift in expectations for how medical device companies manage their quality systems. At its core, QMSR requires companies to take a more process-based and risk-based approach that fully integrates risk management activities throughout the entire product lifecycle and organizational processes.

This episode features:
Naveen Agarwal, Ph.D. - Principal and Founder, Let’s Talk Risk!
Nathan Blazei, Senior Director, Regulatory Affairs, Kymanox
with your host Shannon Hoste, Vice President of Human Factors Engineering at Kymanox

Key Points:

- Risk management can no longer be a separate activity but must be embedded into all quality processes under QMSR.
- Process mapping and understanding information/data flows is critical for building an integrated risk management system.
- A lifecycle approach to continually updating risk assessments based on real-world data is expected, not just a one-time activity.
- The two-year transition period allows companies to identify gaps, update processes, and make a plan to implement QMSR’s risk-based expectations.
- While not mandating ISO 14971 specifically, the FDA acknowledges it provides an excellent model for risk management that most companies should leverage.

About the Factor:

The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.

About Kymanox:

Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management. Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.

The Factor is edited and produced by Earfluence.