Validating Flare for intended use - medical devices

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IFU
Propeller Head
Posts: 48
Joined: Tue Dec 05, 2017 5:28 pm
Location: Vancouver BC

Validating Flare for intended use - medical devices

Post by IFU »

I work for a medical device company where I use Flare to write instructions for use, service manuals, operator's manuals, training guides, etc. The FDA expects us to validate Flare for its intended use. Any thoughts on how I should go about that type of software validation? I got some tips from a post on proving equivalent PDF and HTML outputs viewtopic.php?f=75&t=30831&p=133782&hil ... ts#p133782 but wondering if there is anything else I can learn.
Thanks
Isabelle
mburton
Jr. Propeller Head
Posts: 2
Joined: Thu Aug 27, 2020 7:09 am

Re: Validating Flare for intended use - medical devices

Post by mburton »

I also work for a Medical Device company. Have you learned anything from your research?

Thanks,
Marty
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