Product Specification trace back to the Customer Specification from Marketing

L

LidoSpike

#1
Is it a 21 CFR 820 or MDD requirement that the Product Specification trace back to the Customer Specification from Marketing? The CS is a marketing wish list given to engineering and then engineering comes up with a PS that they can actually build. If it is required where is it listed?
 
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sagai

Quite Involved in Discussions
#2
Hello there,
I am really fan of looking into regulatory sources to see exactly the expectation, however in this case it is quite straight forward for me without without having a read of any of those.
For me, this is coming from the fact that we must ensure that the intended use is fulfilled so forth and looks really obvious when there is an intended use at Marketing, than their customer specification is the elaboration of such intended use and well, we need traceability all way long.
Regards
 

Ronen E

Problem Solver
Staff member
Moderator
#3
21 CFR 820.30:

(c)Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient...
(Emphasis added of course)

How does one ensure that those intended use and needs are addressed if they are not readily traceable from the relevant design requirements? (I read the latter as meaning "engineering requirement specification")
 
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