New episode on The Factor. 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.
Keywords: #lifescience #healthcare #riskmanagement medical devices, FDA 510k process, medical device, regulatory affairs, #fda #qualityassurance
