Risk Management Integration: ISO 14971 in a QMSR World

Description

How to develop, modify and use hazard analysis and the Product Risk Management File and Report per ISO 14971:2019 and ICH Q9 under the new device QMSRs.

The new 21 CFR 820, the QMSR for medical devices emphasizes risk management more than previous. The U.S. FDA has stated that the use of a medical devices entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the ‘state of the art’ at the time. ISO 14971 provides accepted methodologies emphasized more in ISO 13485, a major part of the new QMSR, to perform and document such an analysis as required by the FDA. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 models…