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Subscribe NewsletterFMEA and Risk Management for Medical Devices
Product Id
:
600051
Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 Risk Analysis is obsolete & upgraded to 14971 Medical Devices -- Application of Risk Management to Medical Devices, all facets of risk management must be considered from cradle to grave. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management".
FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 Risk Analysis is obsolete & upgraded to 14971 Medical Devices -- Application of Risk Management to Medical Devices, all facets of risk management must be considered from cradle to grave. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management".
Areas Covered in the Session:
- Failure Mode Analysis Terms
- Risk Management and FDA
- Risk Management in Design Control
- Risk Management & ISO 14971
- Risk Management in Design Control
- Risk Management & ISO 14971
- Risk Management & Medical Device Directives
Who will Benefit:
- Regulatory Professionals
- Quality Engineers
- Manufacturing Engineers
- Operations Executives
- QA Managers