Risk Assessment Checklist for Non product Software

B

Balachander

Registered
#1
#1
Hi,

Can someone share high level risk assessment checklist questions for Non product softwares in a medical device environment. This Risk assessment is to categorize the software as high ,medium and low risk. This step is before acquiring the functional requirements and doing a detailed risk assessment later.

Thanks in advance,
Balachander
 
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Y

yodon

Leader
Super Moderator
#2
#2
Not sure how well suited a checklist would be for ranking risk. I keep it pretty simple and just rank on the basis of (high) a failure could harm a patient, (somewhere in the middle) a failure could result in a major regulatory NC, down to no risk. (By the way, 62304 is for medical device software, not non-product software). I use a 5x5 matrix with the other aspect being likelihood of escape. Works well for me.

It seems most folks have a hard time coming to grips with non-product software harming and, of course, there's no direct harm; but if you consider, for example, software that tracks distribution and you have a recall, if the software fails and not all users are notified, the reason for the recall could recur and thus cause harm. So think in broad terms. I always recommend establishing a Master Validation Plan to set the ground rules.
 
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