Digital Health: QA, RA & CA Forum

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR.

Its simple, but its not.....

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)

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)

FDA Webinar - Clinical Decision Support Software: Draft Guidance (2019)

• Presentation

White paper on EU Software Development Standards

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

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