New Regulatory Expectations and Demands on Integrated lifecycle Risk Management Process and Files
David Rothkopf, President
MEDIcept
11:20 AM - 11:55 AMTue
Several new global regulatory requirements have “upped” the game for integrating Risk Management System (RMS) and Quality Management System (QMS) processes. Regulators are expecting objective evidence of proactive Risk Management Files that are managed across the lifecycle of each medical device family. Notified Bodies and FDA both are writing Nonconformances against Risk Management Files both in the pre-market stages as well as post-market stages of devices, criticizing the lack of continual evaluation and updating. Are you ready for this increased scrutiny?
This session will help you navigate these regulatory landmines.
- Learn about real-life examples of regulatory finding in this RMS/QMS lifecycle processes.
- Engage in discussions in how to integrate these sometimes separate processes and activities within companies.
- Learn the importance of being able to manage regulatory audits to show the integration of Risk Management both within Design & Development stages as well as Post-market stages.