Abstract
One of the most prominent challenges in safety risk management of medical devices is the Benefit-Risk Analysis. This paper proposes a methodology to quantify benefits, thereby creating more consistency, and explainability in the evaluation of benefits and the benefit/risk ratio.
 Leveraging the guidance from the FDA, we define four Dimensions for appraising benefits. The product of the rankings of a benefit in all four Dimensions is used as a quantitative measure of a benefit.
 The quantitative score for the overall benefit of a medical device would be the sum of the scores of the individual benefits.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.