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