Eric Keller wrote:
>
>
> On Thu, Jul 30, 2009 at 10:39 AM, Bolstridge, Andrew
> <andy.bolstridge_at_intergraph.com
> <mailto:andy.bolstridge_at_intergraph.com>> wrote:
>
> I found this from Google, it might help you with other aspects:
>
> http://linuxmednews.com/1018893577/index_html
>
>
>
> It appears that the use of OSS is orientated towards software used
> directly in medical devices, not used to develop that software.
>
>
> Hi Andrew,
>
> first thank you for your rapid answer and the interesting link you
> send me. As you comment on the news, this has more to do with "off the
> shelf" software being part of the final product.
>
> In our case it would be a "help" software to produce our software
> product, therefore I guess an intern validation of subversion
> (meaning, functionalities like tracking changes, and security like
> authorization, backups, ...) will be the issue.
>
> Though I don't exactly know what FDA requires about the software
> process validation, during there inspections...
>
> Sincerely
> --
> Eric Keller
>
I am far from being an expert here, but getting the FDA approval is not
uncommon in medical companies like your (and mine, even outside US). I
think that you should ask CollabNet to provide you with comprehensive
information on this one as I believe they already have been through this
100 times. I have found this article for you to read:
http://www.open.collab.net/news/press/2005/team-edition.html for a
start, but mind not to get yourself in the marketing spiral and commit
to any purchase too quickly (or at all). While Subversion is free, the
rest from CollabNet is not.
Also, mind that configuration management software is just a little piece
in the puzzle to please FDA. You will also need continuous integration
(CruiseControl?) and bug tracking (GForge?, Trac?). You may need some
help from developers and process group in your company to find about
preferences and requirements. I always start on Wikipedia for a list of
software, e.g.:
http://en.wikipedia.org/wiki/Comparison_of_issue_tracking_systems#Bug_Tracking_Systems
Also, someone needs to read these:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
R.
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Received on 2009-07-30 12:33:35 CEST