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Combined Clinical Studies

Wien, 10.12.2024 – Text: Catarina Carrão Combination products Combination products are progressively integrating cutting edge, novel technologies that hold great promise for advancing patient care. Such...

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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Dr. Nora Gedeon

Data Protection Officer (DPO) and Vendor Manager

Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials