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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)
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)