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.....

FDA Webinar - Clinical Decision Support Software: Draft Guidance (2019)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