Is there a regulatory requirement for clinician review for pFMEAs?

QuinnM

Involved In Discussions
#1
Hello –

We are a medical device company. We just added a new risk to our pFMEA, new revision G. When reviewed, I noticed the previous pFMEA revisions have never been reviewed by a clinician. Is there a regulatory requirement for clinician review for pFMEAs?

QuinnM
 
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Jean_B

Trusted Information Resource
#3
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).
 
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