Clinical Evaluation, Investigations and PMCF under MDR

Helene Quie has a degree in Science specialised within cell biology from the University of Odense. Helene has 25 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S,
H. Lundbeck A/S, AMBU A/S and Millimed A/S. Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access
and general management. In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.