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ISO and Human Diagnostic Assays

Richard Schifreen rschifre at access.digex.net
Mon Oct 14 08:24:20 EST 1996

My reading of the proposed new device cGMP's is that they incorporate some
of the ISO regs - especially in the area of design controls.  This is part
of the "harmonization" as the FDA and its equivalents in the European
community move toward more unified regulations.

Rich Schifreen
rschifre at access.digex.net

On 9 Oct 1996, 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.
> -- 
> Bryan Kiehl
> GenBio, San Diego
> GenBio at msn.com

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