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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.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
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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Jun 29, 2021
Jul 08, 2021
Jul 08, 2021