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Harmonised European Standards

Wien, 18.11.2024 – Text: Catarina Carrão The General Framework for harmonised European Standards (hES) Under the MDR 2017/745 and IVDR 2017/746 regulations, harmonized European standards (hES) play an important role....

Clinical Performance Studies of IVDs

Wien, 11.10.2024 – Text: Catarina Carrão In vitro diagnostic (IVD) devices: clinical performance studies Despite extended transition periods and multiple guidelines, IVDR remains difficult to interpret and bringing...

eConsent

Wien, 01.09.2024 – Text: Catarina Carrão Introduction eConsent refers to the process of obtaining informed consent from participants in clinical trials using electronic systems and processes. This...

Clinical Performance Evaluation of IVDs

Wien, 01.08.2024 – Text: Catarina Carrão In vitro diagnostic (IVD) medical devices In vitro diagnostic (IVD) devices play a critical role whether to help diagnose...

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