Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance

N

noemie

#1
I'm working in a litte company in France and we just obtain the certification for ISO 13485:2003 module D (without conception and development process) the 14 of february 2008.
They want to develop the US market and they already make the Pre-market notification 510k. They are already CE marked.
My manager want to know what it's the best strategy for the development of the company.
We start working with a consultant. His recommandation is:
First: implement development process on FDA requirements
Secondly : Stay with annex V or switch with annex II (including conception and development)
I have just finished my studies and I'm new in the professional world. I'm little lost.
I have some additionnal question:
1) It's necessary to have a QMS for USA market. The pre-notication 510 k is not sufficient? isn't it?
2) If we only have the certification ISO 13485:2003 module D, could we sales our medical device on the US market ?

In Europe, the medical device is class IIa and we are annexe V section 3.
3) What will we must to do in order to update our ISO 13485:2003 (module D) to the QMS for US market.

Sorry for my bad english

Thanks for your answers
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Re: up-date QMS 13485:2003 to FDA 21 CFR 820 QRS

To sell in the US market, you need to comply with the US Code of Federal Regulations, Title 21, part 820; a.k.a. 21 CFR Part 820. See:

http://www.fda.gov/CDRH/qsr/contnt.html

Following your 510(k) submission, the FDA will inspect you and then (presuming all ok) grant you permission to market the device in the US.

While it's not sufficient to only have the 13485 certification to sell in the US, you will have most everything you need to be compliant with 21 CFR 820.

I'm sure there are mappings here in the cove showing the similarities and differences between the standards that you could find using the search tool.

Good luck!

P.S. your English is quite good!
 
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