Description: U.S. FDA and EU Notified Bodies have all been writing up Non-Conformances (NCs) against Risk Management Systems (RMS) in a variety of ways. One of the main issues that have caused these NCs is the lack of traceability from Design risk management documentation like Hazard Analysis or dFMEAs to IFUs; IFUs to Usability testing; Hazard Analysis to pFMEAs; and dFMEA, pFMEAs & Usability testing to Post-market RMS files. Learn how to use traceability matrix to “bullet proof” your RMS.
* One lucky attendee will win a copy of RAPS Risk Management Principles for Devices and Pharmaceuticals, Third Edition book.
Learning Objectives:
• Learn how ISO 14971:2019 requires this lifecycle approach.
• Understand the important of traceability matrixes.
• Discuss current practices to prepare for Technical File reviews and QMS audits.