"Certification" is not the issue, and no competent s/w engineer would consider any common Linux distro as a "Fail-Safe" component.
The issue is the ability to have absolute control (compile/link/image locate/config management/version control) for 100% of the source code. Unless you work for a Fortune 100 company, the typical developer working with a Microsoft platform and/or tools has no control of approx 96% of the body of code or of the configuration/image management. luck, Brian > -----Original Message----- > From: [email protected] [mailto:[email protected]]On Behalf Of Jon > Griver > Sent: Saturday, November 11, 2006 12:49 PM > To: [email protected] > Cc: Paolo Peruzzi > Subject: RE: software certification > > Paolo, > > You are more likely to have difficulties with the FDA than > with MDD Notified > Bodies. The best source of information is an FDA document > called "General > Principles of Software Validation". It can be found out: > www.fda.gov/cdrh/comp/guidance/938.pdf > > Clause 6.3 of this document deals with validation of > off-the-shelf software. > The key sentence is "Depending of the risk of the device > produced........the > use of OTS software may or may not be appropriate." > > By the way, I don't think that Microsoft software is any more > 'certified' > for use in medical equipment than Linux or other operating systems. > > Regards, > > Jon Griver > http://www.601help.com > The Medical Designers' Guide to IEC 60601-1 - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________
