Watch Our On-Demand Webinar

On Tuesday, 26 April at 11 a.m. ET, RQM+ subject matter experts hosted a webinar, “An Intuitive Approach to Quantifying the Benefit-Risk Ratio.” Fill out the form to get access to the on-demand recording now.

What You Will Learn

Identification of clinical benefits and robust analysis of the benefit-risk profile have become critical activities in the clinical evaluation process. While ISO 14971 offers information on both quantitative and qualitative evaluation of risk, no such guidance exists for benefit. Consequently, benefit-risk analyses have been purely qualitative despite the subjective nature of these arguments and the regulatory requirement of a quantitative benefit-risk ratio.

Manufacturers are currently facing challenges with respect to how to evaluate and effectively quantify benefit-risk and, therefore, appropriately demonstrate compliance with the MDR. In this webinar, we present methods to quantitatively represent the benefit-risk ratio that have been successful in notified body review.

This webinar will guide you through the core of the clinical evaluation process, beginning with appropriate study outcomes and culminating in a patient-focused benefit-risk assessment. Specifically, it will describe how to:

  • Identify clinical benefits and risks for your device.
  • Determine if a qualitative or quantitative approach to analyzing safety and performance data is more appropriate.
  • Calculate a quantitative benefit-risk ratio.
  • Provide your notified body reviewer with a clear argument to show the benefits of your device outweigh the risks when compared to the state of the art.

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures.

Meet the RQM+ Experts:

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.


Fill out the form to access the webinar