ISO 13485 - Other Documentation specified by Applicable Regulatory Requirements

N

nicoles6

#1
Could someone help me out with an example from 13485:2016 4.2.1e)? Would this be applicable if I also had to comply with the FDA?
Thank you in advance!
 
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Marcelo

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#2
If you apply ISO 13485, the related QMS needs to comply with any applicable regulatory requirement, so yes, the FDA would be applicable too (this is true even in older editions but people seemed to not note or understand it, so we decided to make it very clear on the new edition - but focusing on the QMS and safety and performance/effectiveness regulatory requirements).

Examples are any documentation directly required by any applicable regulation.
 
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