Hello,
When conducting risk management according to 14971 should you document risk controls that are already part of the "prototype" design. For example, a mains powered medical device might be designed with a power cord permanently attached to the device, rather than a detachable power cord, to try and reduce the likelihood of the device losing power. In the risk management should you assume this feature isn't there, assess if the risk is unacceptable, and if so document this feature as a risk control? Alternative should you assume the feature is in place and review how it could fail and document any required risk controls to prevent failure?
Thanks
When conducting risk management according to 14971 should you document risk controls that are already part of the "prototype" design. For example, a mains powered medical device might be designed with a power cord permanently attached to the device, rather than a detachable power cord, to try and reduce the likelihood of the device losing power. In the risk management should you assume this feature isn't there, assess if the risk is unacceptable, and if so document this feature as a risk control? Alternative should you assume the feature is in place and review how it could fail and document any required risk controls to prevent failure?
Thanks