ISO and Human Diagnostic Assays

J. H. MACKENZIE 100023.3435 at compuserve.com
Tue Oct 15 11:22:53 EST 1996


ISO registration in Europe will not be compusory but a full quality system
including design will for certain products when the EU IVD medical devices
directive comes into force.

I am a UK based consultant currently helping several IVD companies achieve
ISO 9001 and EN 46001 ON A WORLD WIDE BASIS

Jim Mackenzie



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