ISO 13485 for Specification Developers

R

rjmeader

#1
Where a medical device company develops the specifications for a device product that is to be manufactured by a contract manufacturer what are the spec developer requirements under ISO 13485? Anyone have any experience with what 13485 provisions must typically me met?
 
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Ronen E

Problem Solver
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#2
Where a medical device company develops the specifications for a device product that is to be manufactured by a contract manufacturer what are the spec developer requirements under ISO 13485? Anyone have any experience with what 13485 provisions must typically me met?
Hi,

I've helped some specification developers build and run their ISO 13485 compliant QMS. The guiding principle is that you need to apply all the sections that pertain to what you actually do. This can mean the majority of the sections, i.e. everything but those that directly relate to production. Perhaps create an applicability matrix where you list all the standard requirements by clauses, indicate applicable/NA, and provide a rationale wherever you put "NA" in.

Please feel free to PM me if you're looking for someone to walk you through. Otherwise, good luck!

Cheers,
Ronen.
 
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R

rjmeader

#3
Makes total sense. Then I presume that the 13485 certificate for the spec developer would exclude those provisions that are not applicable such as production, etc. Correct?

Thanks Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Makes total sense. Then I presume that the 13485 certificate for the spec developer would exclude those provisions that are not applicable such as production, etc. Correct?

Thanks Ronen.
The ISO 13485 certificate includes a short verbal description of the scope the organization has been audited for. For example, if the scope includes designing and manufacturing widgets, the certificate will state "... design and manufacture [and maybe more] of widgets [and maybe other product families]..."; while if no manufacturing was included the word "manufacture" wouldn't be there.

Cheers,
Ronen.
 
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