An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 2015

Topics

• 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

Who should Attend

• Software developers
• Systems engineers responsible for developing requirements
• Quality System auditors
• Test Engineers
• Regulatory Affairs
• Engineering managers and personnel