[Insight-users] FDA approval

[John Biddiscombe]

Luis,

Many thanks for the links. Plenty to read there :)

ttfn

JB

----- Original Message -----
From: "Luis Ibanez" <luis.ibanez@kitware.com>
To: "John Biddiscombe" <jbiddiscombe@skippingmouse.co.uk>
Cc: <insight-users@public.kitware.com>
Sent: Tuesday, November 19, 2002 4:16 PM
Subject: Re: [Insight-users] FDA approval


>
> Hi John,
>
>
> Here are some documents that may contribute
> to the discussion on this topic.
>
> Information about FDA requirement for Software
> Validation are available from:
>
> http://www.fda.gov/cdrh/comp/guidance/938.html
>
> Among the multiple topic addressed in this document you
> may find a set of principles for software validation.
> (in section 4).
>
> ITK uses a pretty robust software development process.
> I will adventure to say that few software projects
> run nightly dashboards on a dozen of different
> platforms/configurations and perform continous builds
> to ensure that errors introduced in the system will be
> detected no later than three hours from their arrival.
>
> The fact of being an open source project also offers
> a natural mechanism for auditing the code. There are
> many eyes around the world looking at every line of
> code. An in-house development project could hardly
> afford such extensive revision.
>
>
> We may probalby say that ITK could be considered as
> off-the-shelf software when used as a component of
> a specific application project. In this case, the
> following FDA document may be of interest:
>
> http://www.fda.gov/cdrh/ode/guidance/585.html
>
>
> The following document provides details about
> the information required on submission for
> FDA approval of software contained in medical devices.
>
> http://www.fda.gov/cdrh/ode/57.html
>
>
>
>
>
>    Luis
>
>
>
> ====================================================
>
> John Biddiscombe wrote:
>
> > Hello all,
> >
> > I went to a job interview the other day and asked the interviewer if
they
> > used things like ITK at all.
> >
> > The reply was essentially, that their software needed FDA approval so
they
> > had to go through a fairly rigorous
> > specification/design/implementation/testing regime that meant they only
> > generally used software written in house.
> >
> > Can ITK be used in projects that require FDA approval? I assume since
lots
> > of medical minded people are using it, this kind of question must have
> > arisen. The testing (thanks to Dart etc) must be second to none. Can
anyone
> > comment?
> >
> > thanks
> >
> > JB
> >
> >
> > _______________________________________________
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> > http://public.kitware.com/mailman/listinfo/insight-users
> >
> >
>
>
>
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