Documenting "bugs" in Medical Devices

Subject: Documenting "bugs" in Medical Devices
From: DSHAPIR1 -at- BWIIL -dot- JNJ -dot- com
To: techwr-l -at- lists -dot- raycomm -dot- com
Date: Thu, 28 Aug 2003 12:43:04 +0200

Question:

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

Is there an alternative terminology for posting "Known Bugs"

Can someone provide me with a specific reference where I can research this
issue, or find examples of how other medical companies handle this issue?

I need your input URGENTLY!

Thanks in advance,

Debbie

P.S. If I get any responses off-list that are helpful, I will post a summary
of responses in a few days




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