Silvia Anghel

Head of IVD Group at Medidee

Dr. Silvia Anghel is the Head of the IVD Group at Medidee, the leading global regulatory, clinical (CRO) and quality service provider for Medical Devices, IVD and Combination Products. Medidee’s IVD Group supports the industry with IVDR transition, providing Regulatory and Performance Evaluation (PER) strategies.

During her PhD, Dr. Anghel performed research in the fields of metabolic disorders, oncology and gastroenterology, developing strong scientific expertise in highly competitive and international laboratories in Canada and Switzerland.

Dr. Anghel then joined the IVD industry where she managed various projects, including product development, manufacturing, and regulatory and quality, which allowed her to gain a valuable overview of the life cycle of an IVD product, from its development to its production and commercialization.

At Medidee, Dr. Anghel and the IVD Group help clients determine the most relevant Regulatory Pathway; evaluate and improve their Technical Documentation, including evaluation of analytical and clinical performance data; and deploy compliant and effective Quality Management Systems. She also provides strategic support throughout discussions with Competent Authorities and Notified Bodies.