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Digital Health: QA, RA & CA Forum

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Its all about the intended use, especially with SaMD.

Here is a guidance on how to write one (this time from the UK)

Crafting an intended purpose in the context of software as a medical device (SaMD)

Dana Manaim-Tirosh

Estimated costs of EU-MDR - this 80 page document has it all (if all you are interested in is Software as Medical Device in the EU-MDR.....)


(it also covers Classification, Technical documentation, post market reporting and everything EU-MDR related)

MDR Guide to SaMD
.pdf
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