An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 2015 covers topics such as:
- The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process
- How are risk management activities integrated throughout the development process
- How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards
- How to control and verify risk mitigations
- What information to include in the Risk Management Plan and Report for better auditability
- The importance of maintaing Risk Management documents in the Post Production era
An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 2015 brings together:
- Software developers
- Systems engineers responsible for developing requirements
- Quality System auditors
- Test Engineers
- Regulatory Affairs
- Engineering managers and personnel