Clinical Benefit – Risk Assessment

Duration: 1 hour  


About the course:

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 analyse 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 analyse this process.

Learning objectives:

o  Introduction to the regulation behind a Benefit – Risk Assessment

o  How to identify and assess device benefits

o  How to identify and assess device risks

o  How does the Benefit outweigh the risks

o  Examples

This 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)

Course Curriculum Overview

  Second Module
Available in days
days after you enroll

Hi, I’m Helene Quie

Co-founder of Qmed Academy and senior advisor. I have 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.

1:1 Online classes with leading Medical Device specialist