Would ISO 13485 be compliant with 21 CFR part 820?
My company sells blue light blocking glasses in the EU. I now want to sell them in the US. I understand they are a Class 1 medical device hence need FDA registration.
As part of FDA compliance I understand I must have and follow a QMS. I understand my QMS is regulated by 21 CFR part 820 and if I understand correctly an ISO 13485:2016 QMS would be compliant with this. Is that correct?
I am therefore interested in your ISO 13485:2016 template which I can use to create my 21 CFR part 820 compliant QMS.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, our ISO 13485 Documentation toolkit is compliant with 21 CFR part 80. Especially, due to the resolution from fall 2020 where FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.
More information on this resolution you can find on the following link:
- Harmonizing and Modernizing Regulation of Medical Device Quality Systems https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202010&RIN=0910-AH99
What is the situation with the ISO 13485 worldwide, you can see on the following link:
- List of worldwide regulations that require implementation of ISO 13485 https://advisera.com/13485academy/blog/2021/03/09/list-of-worldwide-regulations-that-require-implementation-of-iso-13485/
On the following link, you can find Differences and similarities between FDA 21 CFR Part 820 and ISO 13485:
- Differences and similarities between FDA 21 CFR Part 820 and ISO 13485 https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/
You can see how our ISO 13495:2016 documentation toolkit is structured and preview of it on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/
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Mar 30, 2021