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Subscribe NewsletterProper Documentation of Risk Management for Compliance with ISO 14971
Product Id
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600024
Overview: This presentation will deliver a practical discussion on the proper use of the tools available to conduct product risk management and achieve a result that complies and also provides a more complete product risk analysis resulting in reduced cost and impr
There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. However, most manufacturers are only using one tool, FMEA. The other tools are being ignored with a result that often does not meet the requirements of ISO 14971.
There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. However, most manufacturers are only using one tool, FMEA. The other tools are being ignored with a result that often does not meet the requirements of ISO 14971.
Areas Covered in the Session:
- Exploring the Risk Management tool set
- Choosing the right risk management tools
- What tools are used during each phase of design?
- Meeting Human Factors regulatory requirements
- How to document standards compliance
- How to develop an FMEA that meets requirements.
Who Will Benefit:
- Product Risk Management
- Design Engineers
- Human Factors Engineers
- Medical/Clinical Project Team members
- Project Managers
- Process Engineers
- Quality Engineers