software regulation

From: Rob Kall (smile_at_compuserve.com)
Date: 2001-06-09 02:24:25

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Message text written by INTERNET:buildcheapeeg_at_yahoogroups.com
>
Can you be in legal trouble for writing software?
<

The FDA treats software as a device and requires 510K registration, GMP
and proper record keeping and documentation. Software can also go through
ISO 9000, CE, etc.

Rob Kall
Futurehealth, Inc.
211 N. Sycamore St., Newtown, PA 18940 215-504-1700, fax 215-860-5374
www.futurehealth.org
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