Is ImageJ 21 CFR 21 compliant?

[bnorthan (Brian Northan)]

Hi

Does anybody know if ImageJ is CFR 21 compliant??

I have been asked about this a couple of times. However I have no experience with CFR 21. Has anybody else looked into this?? I noticed that some imaging analysis software (for example softmax pro from metamorph) seem to support CFR 21.

Thanks

[ctrueden (Curtis Rueden)]

@bnorthan It would be awesome if someone created a wiki page “Certification” or “Validation” or “Compliance” (probably all of these, redirecting to one agreed-upon official page name) with a list of all these different certifications people ask about, and an explanation of ImageJ’s relationship to them. (Which is to say: basically no relationship, no guarantees, etc.)

Right now the discussions are scattered about in historical threads in various places; e.g.:

• ISO 9001 - http://imagej.1557.x6.nabble.com/IMAGEJ-ISO-certification-state-tt4532455.html
• CoN - http://imagej.1557.x6.nabble.com/ImageJ-Certificate-of-Networthiness-tt3685337.html
• Clinical validation / proof of performance - http://imagej.1557.x6.nabble.com/Validation-tt3697192.html#a3697195
• Helsinki committee validation - http://imagej.1557.x6.nabble.com/validation-for-Helsinki-committee-tt5015279.html

I think the short answer is that there is no one in the ImageJ community who makes it their job to conform to these things. And I think in many cases you have to pay a company to review/audit the software.