ISO 13485 Qualification of R&D Equipment

BexDun

Registered
Hi,

I'm looking for any advise/resources on requirements for R&D equipment qualification under ISO13485/MDSAP.

Is it possible to not validate based on reasonable justification, with R&D being a lower risk than manufacturing/QC? If so how is this documented in the VMP, should there be sub-categories of equipment for operations vs. R&D?

Thanks,
B.
 

yodon

Leader
Super Moderator
If you're using the equipment in V&V, it's clearly a higher risk. If use in other aspects of V&V (development, etc.) then probably a lower risk.

Would need to know much more about your approach, your VMP, the equipment, purpose, etc. before offering any further suggestions.
 
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