ISO 14971 is a risk management standard for
medical devices. Since ISO 14971 introduces its
risk management requirements in sections 3 to 9, the following material begins with section 3. |
3. Establish your risk management frameworkPart 3 of ISO 14971 introduces the
standard and discusses general Part 3 also asks you to assign
responsibility for risk management |
4. Perform a risk analysis for each medical devicePart 4 expects you to use your risk
management file to document |
5. Evaluate risk for each identified hazardous situationPart 5 then wants you to evaluate
risk for each hazardous situation. |
6. Develop risk control measures when risk must be reducedPart 6 then expects you to identify
control measures that can reduce Whenever your residual risk is
unacceptable and further risk control is |
7. Evaluate the overall residual risk posed by each deviceNow that you’ve implemented and
verified all risk control measures, |
8. Review risk management process and prepare reportPart 8 asks you to carry out a risk
management review and to |
9. Monitor device during production and post-productionLastly, Part 9 wants you to
establish a system that you can use to |
Also check out our more detailed version of ISO 14971.
MORE ISO 14971 PAGES Introduction to ISO 14971 Risk Management Plain English Medical Device Risk Management Definitions ISO 14971 Medical Device Standard Translated into Plain English |
OTHER RELATED LIBRARIES |
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Updated on September 16, 2021. First published on February 28, 2011. |
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