Clinical Benefit – Risk Assessment

27 April
09:00 - 10:00


Discuss new Medical Device Regulation requirements concerning a Clinical Risk Benefit Analysis.

Norway Health Tech and our partner Qmed Academy Are offering this 2nd course in our Clinical Evaluation and Assessment Training Series concerning Risk Assessment and the clinical benefit.

The requirements to a solid Clinical Risk Benefit Analysis has increased with the new Medical Device Regulation (MDR). Most Medical Device Manufacturer knows how to structure and analyze related risks, but not many knows how to structure the benefit analysis to be able to complete the Benefit – Risk Assessment. This course will provide you with a method to structure and analyze this process. We will have the following learning objectives:

• Introduction to the regulation behind a Benefit – Risk Assessment
• How to identify and assess device benefits
• How to identify and assess device risks
• How does the Benefit outweigh the risks

Individual course:

  • Member Complimentary
  • Cluster Member NOK 1 000
  • Non Member NOK 2 500

Clinical Course Series (includes Clinical Evaluation (8hr), Clinical Benefit – Risk Assessment (1hr) and Clinical Investigation (8hr):

  • Member NOK 10 000
  • Cluster Member NOK 12 000
  • Non Member NOK 14 000

The course is for Medical device specialists that want to learn or who are already struggling to formulate a solid Benefit – Risks Assessment according to MDR and implement this in the Technical Documentation (Risk Management, Clinical Investigation Plan, Clinical Evaluation and Post Market Surveillance)



Helene Quie

Co-Founder & Senior Advisor - Qmed Academy