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 […]
4 Reasons Why you should Bring your Risk Register from Excel to Jira
4 Benefits of Having your Risk Register in Jira rather than Excel
Agile eQMS to Move Faster & Break Nothing
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira
SoftComply Risk Manager vs Risk Manager Plus on Jira Cloud
Comparison between the risk management apps on Atlassian Jira – the SoftComply Risk Manager and the Risk Manager Plus on Jira Cloud
In Search of a Compliance Solution that Lets You Sleep at Night
How to find the best regulatory compliance solution for medtech on Atlassian
How to Maintain a Documentation Baseline of Agile Development in Confluence?
most popular use cases for capturing and freezing the always dynamic data in Confluence with the SoftComply Static Snapshots app
Change Management & Medical Device QMS on Confluence
How to keep your QMS up to date when regulations and standards change over time with the help of a Compliance Matrix
Display Document Approvals on Confluence Pages with the SoftComply Change History app
display your document approval history on Confluence pages with the SoftComply Change History app
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 […]
How to Report Risks in Jira
Introduction When you manage your product risks in a highly regulated industry, you are well-aware that it is a business-critical and ever-lasting journey. While you may be continuously on this journey, your colleagues, managers and auditors often want to get a quick overview about it. There are those who will want to understand the statistics […]
