This Integrated Risk Management Approach training in ISO 14971 will discuss how to incorporate risk management as per ISO 14971 in all phases of medical device development and what all documentation to be gathered to support the decisions made as a part of risk management process.
Areas Covered in the Seminar: - How are risk management activities integrated throughout the development process.
- The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process.
- How to control and verify risk mitigations.
- How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards.
- The importance of maintaing Risk Management documents in the Post Production era.
- What information to include in the Risk Management Plan and Report for better auditability.
Who Will Benefit:This webinar will provide a methodology that medical device companies can use in establishing a risk management process that is integrated with their product development process. The employees who will benefit include:
- Systems engineers responsible for developing requirements
- Software developers
- Test Engineers
- Quality System auditors
- Engineering managers and personnel
- Regulatory Affairs
