The FDA has auditing guidelines posted on it's web pages for the Quality System Regulation (QSR) that has replaced the old cGMP. From the information I have collected, they are auditing design very closely and they are writing 483s for non-conformities.

http://www.fda.gov/cdrh/drb1.html - FDA Web Site

From: Suzanne Fiorino - cardiotech.com
Subject: RE: Medical Audit/Rothkopf/Fiorino

> I am doing some work with a small medical company that follows: ISO
> 9001, EN46001 and FDA's QS regulartions. The company already has ISO
> 9000, a CE mark and FDA approval on 3 of their products. I have
> remotely assisted them with internal audits in the past, but only on
> sections of the regulations. The company now wants an external audit
> of the entire system conducted by a third party (me) before the ISO and
> FDA guys show up again (in Sept.). I have conducted quality system ISO
> audits before but I have never done a GMP audit of a company. I know
> this is the wrong forum, but I couldn't find a GMP 'consultants' help
> group. Does anyone out there know of a group or have a generic
> checklist to build an Audit Plan.
>
> thanks,
>
> Dave

Since the group has a CE mark, they must have been audited by a Notified Body. Ask your client for their NB checklist which should have both ISO 9001 + EN 46001 + any EC directive items (i.e. MDD or AIMD). These are the EC equivalent to the FDA QSR if their product is classified as a med device.

Marc, Somewhere, I have a copy of the FDA's "guideline" for assessing to the new QSR (reformatted in Word 6.0). Will try to find and forward. By the way, most are correct. The FDA is concentrating on "DESIGN CONTROLS."
Pertaining to the above, just because the unit has a CE mark does not mean thay have been audited by a notified body. That varies with the device "MARKED."

[This message has been edited by Don Winton.]

If you e-mail it to me I'll post it in the pdf_files directory and post a link (which is becoming a catch-all drop directory...).