Software in Medical Devices, by MD101 Consulting

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Thursday, 31 October 2019

Is my software in class IIa, IIb, or III, Dark Fate

Here we are! White smoke over the European Parliament! The MDCG 2019-11 guidance on qualification and classification of medical device software (MDSW) was published the 11th of October 2019.

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Saturday, 6 May 2017

MDR and IVDR published

Hello, The Medical Device Regulation and In-Vitro Device Regulation have been published the 5th May 2017!
See the Official Journal of the EU.