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 From: [email protected] [mailto:[email protected]]On Behalf Of Paolo Peruzzi Sent: Friday, November 10, 2006 6:47 PM To: [email protected]; E-mail Subject: software certification Dear Group, My company is designing a new medical system and for the first time we would like to use an off-the-shelf software as Operating system, and maybe develop some applications running under it. I have heard that for the system CE certification, the third part software could be an issue. It seems that using a "non-certified" software, (like Linux, instead of Microsoft for example) could get us into trouble. Has anybody experience on this matter? Do we have to proceed as we would have developed the whole software (thus providing all the needed documentation on sw development, specifications, risk analysis, verifications and validation)? There is some shortest way or what? Thanks in advance, Paolo Peruzzi Regulatory Medical R&D El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI) Italy Tel. +39 055 8826807 FAX +39 055 8832884 http://www.elengroup.com/ - 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 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 ______________________________________________________________________
