As the only international standard for risk management for medical devices, ISO 14971 has become an integral element for satisfying regulatory requirements in most major markets and should be incorporated into the medical device life cycle.
The purpose of ISO 14971 is to assist medical device manufacturers in establishing, documenting and maintaining a risk management process to: 1) identify hazards and hazardous conditions; 2) estimate and evaluate the associated risks; 3) control those risks; and 4) continually monitor the effectiveness of the controls put in place throughout the product life cycle.
The concepts of ISO 14971 are applicable to the broad range of risks associated with medical devices. This is evidenced by its reference in numerous medical device standards, including the third edition of IEC 60601-1 (electrical safety), IEC 62366 (usability), ISO 13485:2003 (quality) and IEC 62304 (software), among others.
This class will provide participants with not only an understanding of the ISO 14971 concepts, but also direct, hands-on experience in applying the concepts through a Case-Study. Additionally, the course will discuss the expectations associated with the EN ISO 14971: 2012 edition of the standard. Please make sure to bring your copy of the standard EN ISO 14971 2012 Edition to the workshop.
- Introduction to risk management
- Risk management policy and plan
- Definitions and Risk Acceptability
- Intended use and hazard identification
- Risk estimation and evaluation
- Option analysis and risk control
- Risk Management report and post production information
- ISO 14971:2012 Content Deviations from the Essential Requirements, and Expectations for the Technical File