Getting Linux system approved by FDA.

Sundar plug-discuss@lists.plug.phoenix.az.us
Mon, 19 Aug 2002 14:51:09 -0700


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
>>
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