Posted by
ctrueden on
Dec 24, 2015; 1:01pm
URL: http://imagej.273.s1.nabble.com/validation-for-Helsinki-committee-tp5015279p5015280.html
Hi Aryeh,
> A Helsinki committee has asked whether FIji/ImageJ have "validation".
My understanding is that ImageJ would not "have validation" itself. Rather,
the organization using it for some purpose (e.g., designing or
manufacturing a medical device) must somehow ensure the software is
appropriate for that purpose.
In the U.S., from the FDA's web site's validation guide [1]:
"Where the software is developed by someone other than the device
manufacturer (e.g., off-the-shelf software) the software developer may not
be directly responsible for compliance with FDA regulations. In that case,
the party with regulatory responsibility (i.e., the device manufacturer)
needs to assess the adequacy of the off-the-shelf software developer's
activities and determine what additional efforts are needed to establish
that the software is validated for the device manufacturer's intended use."
Do you have a link to the Helsinki committee guidelines for comparison?
Regards,
Curtis
[1]
http://www.fda.gov/RegulatoryInformation/Guidances/ucm085281.htm#_Toc517237930On Thu, Dec 24, 2015 at 2:46 AM, Aryeh Weiss <
[hidden email]> wrote:
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