As Marcelo states there is no requirement for clinicians to review or approve a process
FMEA.
This is also (mostly) lgoical, as the clinician would not be providing expertise related to any of the process' inputs, processing or output risks.
Usually a risk of the process has an influence on the device, and may result in a failure mode of the device occurring. For these failure modes of the device (which may impact a patient through some foreseeable sequence of events) it
is logical to have a clinican involved to assess them.
Beware though if you have a company doing process FMEA's whose effects stretches all the way to user/patient harm. (These are both burdensome to keep up-to-date and hard to maintain and read).
