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Risk Management and FMEA

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Guest user Created:   Jun 29, 2021 Last commented:   Jul 08, 2021

Risk Management and FMEA

I am working on completion of our Risk Management Procedures. Is FMEA required for Class I devices, or is there a simpler alternative we can use?  
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 08, 2021

FMEA is the risk method that best meets all the requirements of ISO 14971: 2019, so it is recommended that it be used for class I medical devices.

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