Expert Advice Community

Guest

21 CFR 820 / ISO 13875

  Quote
Guest
Guest user Created:   Dec 15, 2020 Last commented:   Dec 16, 2020

21 CFR 820 / ISO 13875

We are registering with the US FDA. I have determined if I get compliant with ISO 13875 I can pretty much meet the requirements of 21 CFR 820. It appears your company is not based in the US. I would like to use it to build our QMS. At some point, we will be attempting to bet ISO 13875 certified but at this point it is not required. Please advise. Thank you.

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 16, 2020

I assume you meant ISO 13485. Yes, you are right, there are a lot of similarities between ISO 13485 and FDA 21 CFR 820. 

The best ways to see what are similarities and differences between these two standards is on the following link:

There is a proposal sent by FDA to transfer completely on the ISO 13485. This proposal was sent in 2018 and in 2020 decision was expecting. However, so far it is not legal yet. The main reason why the FDA was thinking of this transfer is that ISO 13485 is globally recognized as a quality management standard for medical device manufacturers.

For more information, see:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Dec 15, 2020

Dec 16, 2020