IS9001 seems to be the standard for production/design of medical devices
(including in vitro diagnostics). ISO 9002 pertains more to manufacture
only of in vitro biologics. I believe if you have any deisgn criteria you
In USA you still need to comply with GMP (which will incoporate most of
the ISO requirements but not all).
For European sales, you will need ISO registration before long. Many USA
based firms are also "requesting" ISO registration before they will buy
bulk OEM material or finished devices for export.
FDA regulation will always be more stringent and a better overall
indicator than ISO . ISO is a paperwork trail audited by paid
There are many different auditors and you will find many different
interpretations of these new regulations.
You may wish to enguage a USA based consultant before starting the
process. I am told you better expect to pay $20-30K to obtain registration
assuming you already have evrything well documented (FDA GMP X 10).
I know of one auditor you may wish to contact for an initial reveiw:
Don Cox, Goldmark Biologicals,NJ phone 908-859-2631
see his web site: http://members.aol.com/goldmarker
Bret G Wien
Research Diagnostics Inc