Major differences between 21 CFR Part 820 and ISO 13485?

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abchris

#1
We currently have a quality system based on CFR part 820. What we would have to add to be complaint with ISO 13485?
 

GStough

Staff member
Super Moderator
#2
Re: Major differences between part 820 and iso 13485?

We currently have a quality system based on CFR part 820. What we would have to add to be complaint with ISO 13485?

Hello abchris, and welcome to the Cove! :bigwave:

Here is a thread that may answer your question, and a file attachment that you may find useful in determining the differences between 21 CFR Part 820 and ISO 13485:2003.

Comparison of 21 CFR 820 and ISO 13485

If this doesn't adequately meet your needs, there are other discussions in the ISO 13485 - Medical Devices forum (scroll to the bottom of this page and click on the drop-down menu for the forums) that may have more of what you're looking for.

I hope this helps. :cool:
 

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