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Risk analysis Medical Devices
Risk analysis Medical Devices
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Risk analysis Medical Devices
This risk analysis (in XLS) contains the safety requirements of the Medical Devices Regulation (EU) 2017/745. The Fine & Kinney method is integrated into the XLS.
The document consists of 4 tabs:
- Cover page
- Legend (with information about the risk calculation)
- A sheet with the minimum safety requirements
- and a sheet for the risk calculation
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