Navigate the risk management maze: Benefit-risk analysis made easy

#iso14971 #riskbenefit #medicaldevices
Every medical device needs a benefit-risk analysis for overall residual risk evaluation, but where does one start?

In this seminar you will get a step-by-step guidance on how to make a successful benefit-risk analysis, illustrated by real-life examples.

Presented by: Cristina Barkman, co-author of ISO 14971:2019 and ISO/TR 24971:2020, senior consultant at QAdvis AB.

Thanks for watching! Start your free trial today at http://www.aligned.ch

0:00 Introduction
0:06 QAdvis - Key competence areas
1:25 Presentation of the trainer Cristina Barkman
2:28 Risk management process
3:49 When is benefit risk analysis needed?
6:23 Overall Residual Risk Evaluation
11:15 Guidance for Benefit-Risk Analysis
12:48 Possible approach
13:51 Benefit - Definition
14:22 Benefits include
15:35 Data Sources
19:09 Consider benefits in terms of
21:00 Address Uncertainties for the Benefits
25:13 Consider residual risks in terms of
27:57 Address Uncertainties in Residual Risks
31:28 Overall Benefit-Risk Analysis
34:25 Narrative example
35:47 Evaluation of the Benefit-Risk balance - Example
36:35 Common pitfalls
39:12 Take-Aways

This recording was broadcasted during an Aligned Sharpen your Skills event.

Start a free trial: https://www.aligned.ch/free-trial
Visit our website: https://www.aligned.ch
Connect on Linkedin:   / aligned-ag