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Medical Device Design Control Auditor Recommentations

#1
I'm soliciting recommendations for a certified lead auditor qualified to perform a multi-day internal audit of my company's medical device design controls in the California bay area within the next month or so. The ideal candidate would have significant practical experience developing and auditing class 2 software controlled electro-mechanical medical devices against US FDA 21 CFR 820 medical device regulations, ISO 13485, ISO 14971, and other global design-related standards and regulations. Experience with CE marking and technical files would be a plus.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Why audit the design controls only, and not the design process (including design controls) as a whole? Experience shows that the problems with design controls usually happens because the design process is not understood or followed correctly.
 

yodon

Staff member
Super Moderator
#4
You might consider reaching out to the local ASQ group. They might have an audit group that could identify some candidates.

I have a few contacts in that area and would gladly get you connected with them. Send me a private message if you want to try that route.
 

Watchcat

Involved In Discussions
#5
I like it that you just want to focus on design controls. What is your reason for auditing them? Do you want to confirm that all is well prior to a regulatory submission or in anticipation of a postmarket regulatory audit?
 

Watchcat

Involved In Discussions
#7
You might consider reaching out to the local ASQ group.
That would be an excellent source if the local ASQ group has a tilt toward medical devices, but I'm not sure how many ASQ groups do. RAPS has an active chapter in the Bay area, which I would usually expect to be a more reliable source for medical device RA and QA experts.
 
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