Dr Silvia Anghel

Associate Director

Silvia Anghel developed a strong scientific research expertise in highly competitive and international laboratories in Canada and Switzerland, performing research in the fields of oncology, metabolism-related disorders, and gastroenterology.
She also acquired an industrial experience by working in different positions in the In Vitro Diagnostics (IVD) industry. Silvia managed various projects, including development, manufacturing, regulatory and quality and gained a valuable overview of the life cycle of a product from its development to its production and commercialization. Silvia is the Head of Medidee’s IVD group, overseeing activities related to IVDR transition, and providing Regulatory and Performance Evaluation (PER) strategies. She helps you to determine the most appropriate (and pragmatic) regulatory pathway, to evaluate and improve your Technical Documentation, including evaluation of your analytical and clinical data, to deploy a QSR and/or ISO 13485 certified QMS and finally, she supports you throughout discussions with Competent Authorities and Notified Bodies. Silvia speaks French, English and Romanian.