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ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits

pbojsen

Involved In Discussions
#1
I work for a manufacturer of FDA regulated products, but some of them are FDA classified as Class I, GMP exempt. That means I am only required to keep records and complaints. No design files are required, no medical device file, etc.

However, ISO 13485 says I do have to have design files, medical device files, and all the other applicable documents in the standard.

The question is, does the FDA requirement trump the ISO standard, or am I required to have what the standard calls for regardless of FDA product classification?
 
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William55401

Quite Involved in Discussions
#2
It really depends. Where do you distribute your product? For the USA, class I GMP exempt is an express lane. The bar may be higher in other geographies where 13485 is must
 

Gisly

Starting to get Involved
#3
The scope of your ISO13485 certificate should be clear on this. Ex.- exlude Design and Development, or be specific on which product(-lines) is covered by the certificate.
 
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