White Paper: Benefit-Risk Determination: A Quantitative Approach

In the absence of clear guidance about the specific methodology for quantifying benefit-risk of medical devices, manufacturers are facing challenges with demonstrating compliance with the requirement for a quantitative benefit-risk analysis.

Our white paper addresses this challenge with a suggested methodology and associated examples that have successfully gone through notified body review.

This white paper covers::

  • Notified body reviewer insights from Dr. Jai Kutty
  • Benefit-risk requirements under EU MDR
  • How to determine and evaluate benefits and risks from Dr. Bethany Chung
  • How to evaluate the benefit-risk ratio
  • Specific device example calculations of the benefit-risk ratio

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Meet the Authors:

Bethany Chung

Bethany Chung, Ph.D., RAC

Principal Regulatory Scientist

Bethany has a Ph.D. in biomedical engineering and loves all things quantitative. She has more than 10 years of experience with medical devices in the clinical space. Prior to joining the regulatory world, she was a clinical researcher specializing in ML and AI-based devices, and she is currently in the Clinical and Post Market Practice at RQM+.


Jaishankar (Jai) Kutty, Ph.D.

VP, Intelligence & Innovation

Jaishankar "Jai" joined the RQM+ clinical team in February of 2021 after seven years at BSI where he held CE marking technical and clinical leadership roles. He is the captain of his underwater bowling team that can also build suspension bridges using floss picks and paper clips. If that means nothing to you, when he is not running with the queen or waltzing with the bulls, he is best at leveraging his unique blend of expertise combining cardiovascular product development and CE marking-experience, towards supporting our clients with regulatory solutions and developing clinical strategies. His fresh-from-the-notified body perspective brings great insights and creative approaches to our clients.

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