Getting Linux system approved by FDA.

[Craig S.]

> 
> Message: 2
> Date: Mon, 19 Aug 2002 11:13:18 -0700
> From: Sundar <linux@esaravana.com>
> To: plug-discuss@lists.plug.phoenix.az.us
> Subject: Getting Linux system approved by FDA.
> Reply-To: plug-discuss@lists.plug.phoenix.az.us
> 
> Hello,
> 
> Finally, I managed to convince our management to get a Linux based test 
> system to test our products(Pacemakers, De-Fibrillators.....) . Now I 
> have to decide on RedHat, SuSE or any other and get it approved by FDA. 
> I know, it's going to be a long time(6 months to an year). Documentation 
> itself is going to take atleast 3 months.  But, I guess it is better 
> late than never.
> 
> Now to the question -- Have any of you implemented the systems like 
> this(testing medical electronic equipments or electronic equipments in 
> general). We will be using LabVIEW(from National Instruments) to develop 
> the applications. I need your anecdotal experiences and others, if you 
> have come across similar situations.
> 
> And what do you think as the good company to go with. I have good 
> exposure to RedHat, decent exposure to SuSE  and played around with others.
> 
> Any pointers welcome.
> 
> Thanks,
> Sundar
> 
> 
> --__--__--
> 


I believe you are going to need to read the Real Time Operating System (RTOS) how-to. As someone else has already stated be liberal with the wording on your documentation so that you can upgrade libraries and kernels as needed or you will fast find yourself with an outdated system (I hate gov't documentation but it does serve a purpose). You will also want to read the Linux From Scratch how-to. For your purposes I would steer clear of any set distro as this will give you the greatest leeway for upgrading in the future. Personally I steer clear of RPM's as well but you can make up your mind as to what type of pkg. management you want to use.

Craig S.