Hi,
We do supply packaged ASIC (application specific IC) to customer that manufacture medical devices. Our ASICs are not considered medical devices, and we have received ISO 13485 certification. Does this mean that we should also fulfill the requirements of ISO 14971? If yes, how can we evalaute the benefit of our components?
Regarding ISO 13485 clause 4.2.3, is it correct to consider this not applicable since we do not manufacture medical device, and we do not have medical device files?
Thank you.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
We do supply packaged ASIC (application specific IC) to customer that manufacture medical devices. Our ASICs are not considered medical devices, and we have received ISO 13485 certification. Does this mean that we should also fulfill the requirements of ISO 14971? If yes, how can we evalaute the benefit of our components?
Yes, ISO 14971 is mandatory for anybody who implements ISO 13485 according to the requirement 7.1 Planning of production. If your risks after implementing control measures are acceptable, then calculating the benefit /risk ratio is unnecessary.
Regarding ISO 13485 clause 4.2.3, is it correct to consider this not applicable since we do not manufacture medical device, and we do not have medical device files?
No, points from requirements 4 and 5 are not possible to state as non-applicable. For you, it is enough to prepare a file where you will put some kind of specification and/or code. Nothing else is necessary for your type of product.
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Oct 02, 2024