Clinical Evaluation, Investigations and PMCF under MDR

Clinical Evaluation, Investigations and PMCF under MDR

Course Time 33 Min
$75 Per person


Helene Quie
Helene Quie
Member of the Board, EAAR, CEO, QMed Consulting, Denmark
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.


A brief overview of regulatory requirements for medical device Clinical Evaluation and Investigations pre- and post-CE mark according to MDR 2017/745 and IVDR 2017/746. Strategies on how to successfully migrate to MDR and IVDR, having in mind new challenges and recommendations from the MDCG guidelines, for example use of equivalence MDCG 2020-5 or sufficient clinical evidence for legacy devices MDCG 2020-6.

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