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Re: Documenting "bugs" in Medical Devices

Subject: Re: Documenting "bugs" in Medical Devices
From: "Diane Evans" <diane_evans -at- hotmail -dot- com>
To: DSHAPIR1 -at- BWIIL -dot- JNJ -dot- com, techwr-l -at- lists -dot- raycomm -dot- com
Date: Thu, 28 Aug 2003 05:55:02 -0700

What is the INDUSTRY Standard for handling the distribution of "Known Bugs"
for medical devices (SOFTWARE specific, not hardware?)


When dealing with medical devices, you are most likely concerned with FDA regulations, otherwise known as 21 CFR Part 11 and similar regulations.

There is a Yahoo group, http://groups.yahoo.com/group/21cfrpart11/ , that has experts who can help you. You can also check www.21cfrpart11.com and www.labcompliance.com for more information.

Although I don't deal with medical devices, I do work in the realm of biotech. I call my bugs "Deviations."

Diane Evans
Technical Writer

Washington State Coordinator, Tombstone Project
http://www.rootsweb.com/~cemetery/washing.html

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