Clear differences between ISO 13485 and AS 9100D requirements

Al Rosen

Staff member
Super Moderator
#11
Hello Everyone:

I would like to get some idea about one could address the event where the product is a biochemical, the customer is the DOD, the manufacturing environment is cGMP and the DOD guidance is AS9100 / FAR? It appears that the ISO 13485 would be applicable with some modification for the product being controlled by the FDA. AS9100 would require attention be given to "Counterfeit components", Domestic Sources for Chemicals, Continuous Improvement, and FAI. Your thoughts on the appropriate standard(s) for this application.

George
At this time FDA does not recognize ISO13485 registration and has it's own set of rules, 21CFR820. There are rumors that they are considering adopting ISO13485. It was supposed to happen in the fall of 2019. Change is slow in the federal regulatory world.
 

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