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eQualityTime / TheOpenVoiceFactory

The Open Voice Factory - open software for people with communication difficulties
http://theopenvoicefactory.org
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Clinical Evaluation #104

Closed greg-westnine closed 3 years ago

greg-westnine commented 6 years ago

Something we may have missed in our initial set of tasks, the Med Dev directive, Annex X says" 1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where: — there is demonstration of equivalence of the device to the device to which the data relates, and — the data adequately demonstrate compliance with the relevant essential requirements. 1.1.2. Or a critical evaluation of the results of all clinical investigations made. 1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2."

joereddington-public commented 6 years ago

That's doable - are we thinking a page? (It's mostly going to be me citing these)

greg-westnine commented 6 years ago

Those references seems like what we're looking for. I'm not sure the length matters so long as it does point 1.1.1 above