ISO and Human Diagnostic Assays

J. H. MACKENZIE 100023.3435 at compuserve.com
Mon Oct 14 05:18:19 EST 1996



--------------- Forwarded Message ---------------

From:   J. H. MACKENZIE, 100023,3435
To:     Bryan Kiehl, INTERNET:GenBio at cts.com
Date:   Wed, Oct 9, 1996, 17:35

RE:     ISO and Human Diagnostic Assays

I am a consultant specialising in Quality and regulatory matters in the
medical devices and in vitro diagnostics field.


To answer your questions

1. ISO 9000 is a general quality systems standard and does not apply to any
products but to systems. EN 46000 is for the application of ISO to medical
devices.

2. A new European Directive is being prepared which will apply to all IVD's
sold in Europe. This will entail CE marking of products. ISO registration
may or may not be necessary depending on the class of IVD. In my opinion it
will be the best route.

3. There will be so called Harmonised Standards which will apply to IVD's.

4. I could write pages on this subject but I hope you appreciate that I
make my living by advising companies such as yours on this subject.

regards

Jim Mackenzie.

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