Times New Roman]Can anyone tell me what the FDA or EU requires for the management of installed medical devices that are PC based and use OTC S/W planned for obsolesence in FY04? This seems to be a question that impacts a lot of PC based medical devices. The entire concept of managing a product for the life of the device (based on company policy) goes out the window when we can no longer support the product in the field when a customer upgrades their operating system on their PC (i.e. our product wouldn't work properly - reference MS going from NT to 2000)

Hello and welcome at the cove ;)

I know this problem very well. There are many solutions on the market, which are MS-Windows based. They usually support some of the various versions.

Most of the (chemical)analysis devices work together with NT4 or Win2k, the newer ones with WinXP. But no one knows how long there will be support for these operating systems. MS cancels the support for NT4 soon. And yes, that might be a problem, that remains unsolved. OTOH NT4 is a stable pladform, so it will work for another 10 years (I am working with NT since 10 years). [Most of the so called "important" manufactureres do not care on these issues, One can buy their systems, or not (thats the reality)]

I disagree with all of these upgrade-junkies who always want to have the newest systems.

In case of critical applications the stability of the system should have priority. And in this case it should be acceptable to use the same operating system for a period of 5 years (and this can be 2k and/or XP).

It is possible to use NT clients in a 2k environment (I have validated such a GMP-environment with NT clients one year ago, and these systems will be used another 3-5 years).

[finally found it]

There is a FDA-Guide for
Off-The-Shelf Software Use in Medical Devices (http://www.fda.gov/cdrh/ode/guidance/585.html)

Maybe you can find the one or other specific answer there.