Yeah, the FDA isn’t as invasive as the FAA; although they can have
surprise inspections where they just turn up in your cube, asking you
where your engineering notes for the last few days are (asking the
auditor what exactly they mean when they refer to “engineering notes”
would undoubtably elicit an amusing response - not that I have ever had
the opportunity to try this out
From: Igor Kovalenko [mailto:Igor.Kovalenko@motorola.com]
Posted At: Wednesday, April 25, 2001 12:58 PM
Posted To: advocacy
Conversation: WindRiver buys BSD - new competition for QNX?
Subject: Re: WindRiver buys BSD - new competition for QNX?
Don’t know about FDA, but I’ve heard from involved people that when you
want FAA approval they actually set up office on your premises and keep
walking around, watching and checking. It is like having SEI people on
campus, only worse
Rennie Allen wrote:
With direct life support things get only more complicated I suppose.
Actually, the FDA really doesn’t care about Posix/FIPS/ISO for a COTS
vendor. They do care about FDA processes being followed by the actual
device vendor, and that any software that makes up a part of the
has a “responsible party” (the discussion was originally about using
free software as part of a safety critical system).