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Digital Health: QA, RA & CA Forum

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mdcg_2020-3_en
.pdf
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Guidance on significant changes regarding the transitional provision under Article 120 of the MDR.


Its simple, but its not.....


D M

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)

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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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Are you an edge case with respect to medical device software and the EU-MDR? Are you looking to delve into the details of the European regulation? Then this is the document for you!! Detailed analysis and comparison of the MDR with respect to software as medical device. Enjoy??

MDR-Impact-Papers-SOFTWARE
.pdf
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White paper on EU Software Development Standards

EU-MDR White paper Medical-Device-Software-Development
.pdf
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D M

Here is the EU-MDR Guidance on Qualification and Classification of Software in Regulation

EU-MDR MDCG guidance_qualification_classification_software mdcg_2019_11_
.pdf
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D M

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    Welcome to the group! Here in the digital health QA, RA, CA...
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