Getting Linux system approved by FDA.

Top Page
Attachments:
Message as email
+ (text/plain)
Delete this message
Reply to this message
Author: Sundar
Date:  
Subject: Getting Linux system approved by FDA.
Thanks Blake. It will be good from management point of view to deal with
another company and pay for it's services. This way they will take
things seriously, rather than just as one time deployment or just to
accommodate me. We pay real big bucks for each tester currently (eg. 300
MHz pentium II hardware, nothing fancy is $9000, only thing is if any
part goes bust the company will supply the same model anytime in next 10
years) . And when I checked Redhat/SuSSE, even with service agreements,
we would almost save 70% - 85%.

On getting locked to particular version of the distro, it is inevitable.
We have to get it certified even if we add some more memory to any
existing testers. In fact, I am administering 200 to 300 testers
worldwide running VENIX(really old AT&T version of Unix) with 16MB ram.
We cannot upgrade it or do anything else. One good thing is they have
been humming with a hitch, not the newer Windows NT systems. Everyday at
least 2 blue screens of death(go figure!).

So, if this certification goes through I will be locked to the version,
license agreements etc... for next 20 years for initial 150 testers at
least.

Cheers!
Sundar

Blake Barnett wrote:

>All I can say, is be VERY careful (or liberal) with the wording you use
>to get the certification. At a past employer, they were too literal
>with their definitions and we were stuck at an old version of the OS
>specified, and weren't allowed to upgrade without re-certification! So
>just be careful.
>
>I'd recommend Debian, but you'll get 20 different answers to which
>distro to choose.
>
>
>On Mon, 2002-08-19 at 11:13, Sundar wrote:
>
>>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
>>
>>________________________________________________
>>See http://PLUG.phoenix.az.us/navigator-mail.shtml if your mail doesn't post to the list quickly and you use Netscape to write mail.
>>
>>PLUG-discuss mailing list -
>>http://lists.PLUG.phoenix.az.us/mailman/listinfo/plug-discuss
>>