ISO 14971 Applied to Software

#1
Recently, I'hve been assigned to perform a risk assessment of a medical device with software, I come from non-software implantable Medical Devices and I don't know how to start the risk assessment for the software.

Is there any guidance or examples for the risk assessment of the software such as the examples in ISO 14971 for Medical Devices?
 
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yodon

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#3
I don't have that standard, but the info in the link provided refers to old revisions of both 14971 and 62304. Probably good info on the approach but probably necessary to be cognizant of the changes, especially to 14971.

On a slight tangent, depending on the application, you may also need to consider cybersecurity (in parallel with the software risk assessment). Everybody's on the bandwagon now (I think all countries have some form of guidance doc).
 
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