Holy cosmic implications, Batman.... Please excuse my irreverent attitude, but this analogous to using a Los Angeles freeway as an appropriate site to teach a 5-year child to ride a bicycle.... In any case, your corporate website would seem to indicate that you have software development professionals that should have been consulted prior to this august group.
Are you certain that you need an OS ? What about just a scheduler ? What about just a static memory manager (i.e., no dynamic allocation, NO heap) ? If this is your first project using an OS for embedding into a medical device, please find an expert, and be prepared to make life miserable for your programming team. Do NOT select an OS unless you have an "institutional infrastructure" built for that OS. If any code can be considered a safety-critical component, then read IEC/EN 61508-x series; and you must understand the basis of the SIL. If you use C, buy and study the MISRA standard. Perhaps, also read MIL-STD-882C and DO-178. The (U.S.) FDA website has a lot of good stuff on software validation. While I cannot endorse any of the following companies (I have used some of their products), they are all mature and have earned decent reputations for robustness in the hi-rel embedded market: Greenhills VxWorks Micrium MontaVista BlueCat Wind River Systems Lynuxworks luck, Brian > -----Original Message----- > From: [email protected] [mailto:[email protected]]On Behalf Of Paolo > Peruzzi > Sent: Friday, November 10, 2006 8:47 AM > 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 > 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 ______________________________________________________________________
