ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause.

FloridaST

Involved In Discussions
#1
While reviewing our procedures as I normally do to fill in gaps, make corrections or additions, I realized we don't have a procedure documented for 8.2.3. We do make what the FDA considers a "finished device" for a customer (even though I disagree but, I digress). What's an effective way to approach 8.2.3? I don't know what a notification to the appropriate regulatory authorities would even look like.
 
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FloridaST

Involved In Discussions
#4
Thank you and yes we're based in the USA. What we do is make a device for our customer that has design control, we're just the labor. I can piece something together that should work for us, thanks for the assistance.
 

Ronen E

Problem Solver
Moderator
#5
Thank you and yes we're based in the USA. What we do is make a device for our customer that has design control, we're just the labor. I can piece something together that should work for us, thanks for the assistance.
In FDA terms it's called a Contract Manufacturer - CM (and your client is the Specification Developer).
You might want to delve into FDA guidance to understand your particular responsibilities (or lack thereof) as a CM, depending on the SPECIFICS of your commercial/distribution arrangement with your client. If might affect your actual reporting/notification obligations.
 
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