ISO 13485 Class I Medical Device Design Exclusion

Ronen E

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#11
The Essential Requirements state in a number of locations, "The devices must be designed (...)", followed by a specification for particular required performance or other characteristics. It is at least a common interpretation of this set of stated requirements that the design process, just as the manufacturing and packing processes in certain cases, must be controlled so as to accomplish the stated requirement...and of course, as a general requirement in line with the universal dictum that "if it's not documented it didn't happen", that design process must be documented.

I gather that you're arguing for an alternate interpretation of the "must be designed, manufactured and packed" requirements, in which there isn't any requirement for control of processes as long as the device outcome is acceptable. I don't think the rather extensive historical record of drafter intent supports an interpretation that doesn't include control of processes, though. Certainly that's the understanding that's expected by the regulatory parties with which my employer interacts.
I used the word "explicit" for a reason. Surely the one you present is a legitimate interpretation, but I can assure you that "not a few" regulatory parties accept alternative interpretations.

To me, "Design Controls" is more than just documenting your design (even more than documenting your design process). As an engineer, I can't imagine any commercial production of devices without any design documentation. That's not the point. I perceive "Design Controls" as a rather clearly defined set of measures, similar to those prescribed in 21 CFR 820.30 or ISO 13485:2003 s. 7.3. I was commenting about a clear mandatory requirement to implement this type of measures.

Control of manufacturing processes is a separate issue.
 
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