Declaration of Conformity - Structuring

M

MarkinCalifornia

#1
I have a question on the structuring of the Declaration of Conformity (DOC). The company I work for is seeking to market a system composed of medical devices and accessories. We have structured our technical files so that the system is divided up into three subsystems with a technical file associated with each. When drawing up the DOC, do I need a DOC for each subsystem that references the particular devices and accessories that makes up that subsystem or do I create a single DOC for the entire system that lists all the components (from all 3 technical files) that makes up the system? Thanks for your help.
 
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chris1price

Trusted Information Resource
#3
Hi

I would agree, put them together onto one Declaration. However sometimes customers do ask for copies, so for convenience I tend to group them by product family to avoid sending many unnecessary pages out.

Chris
 
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