Re: [FDA] approval

On Thu, Jul 30, 2009 at 10:39 AM, Bolstridge, Andrew <
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
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