What is a Benefit-Risk Analysis & How To Do It?

The Benefit-Risk analysis (a.k.a. Benefit-Risk determination or Benefit-Risk ratio) is one of the most misinterpreted areas of the Risk Management process, in particular when coupled with the requirements of MDR / IVDR. And consequently one of the preferred digging points for the Notified Bodies. The spirit of the regulations and standards is “the benefit provided […]

SOFTCOMPLY RISK MANAGER IS NOW CLOUD FORTIFIED

Introduction Last week we reached an important milestone – the SoftComply Risk Manager on Jira Cloud was awarded the Cloud Fortified badge by Atlassian. The SoftComply Risk Manager is the only product risk management app on Jira and the most customisable one with Risk Management guidance, multiple views to work in and compliant Risk Reporting. To learn more about the SoftComply Risk Manager on Jira Cloud, please book your […]