ISO 14971:2019 - Application of Risk Management to Medical Devices Overview
1 hour and 20 minutes
ISO 14971 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s QMS.
This two-hour self-paced risk management eLearning presents the key foundations of the risk management process defined in ISO 14971 and provides expert tips on how to navigate the process.