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