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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)

D M

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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FDA Webinar - Clinical Decision Support Software: Draft Guidance (2019)



FDA Presentation on Clinical Decision Support 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

here is the list of FDA guidance's for digital health (SaMD & SiMD)


https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content

List of FDA Guidance Documents with Digital Health Content
.pdf
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D M

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