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 email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________
