I am very interested in receiving the comments by newsgroup members on this
topic too. Please post replies publicly to the newsgroup
(diagnost at net.bio.net).
Thanks,
Mark Hughes
RapidTest Diagnostics International, Inc.
**********************************
In a message dated 96-10-09, Bryan Kiehl wrote:
> I work in a medium size company that makes immunoassays for both the US and
> European markets. In most cases we sell these through various
distributors.
>> We comply with GMP and GLP, but have only been monitoring the ISO regs. At
> this time, it is my understanding that ISO does not apply to most
> diagnostic kits.
>> I would be interested in various comments about the following subjects:
>> CE marks; can they be established without ISO registration
>> ISO as it relates to in vitro diagnostics
>> Any other related issues.
