Benefit Risk Assessment

Benefit Risk Assessment

Course Time 18 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.


Most Medical Device Manufacturers knows how to structure and analyse related risks, but not many knows how to structure the benefit analysis to be able to complete the Benefit – Risk Assessment. Helene will provide you with a method to structure and analyse this process according to the new medical device regulations.

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