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Marion Lepmets
CEO
March 17, 2023
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...


Marion Lepmets
CEO
March 6, 2023
WHITE PAPER ON REGULATORY REQUIREMENTS AND BEST PRACTICES FOR VALIDATION For More News on Validation:
...

Marion Lepmets
CEO
February 20, 2023
4 Benefits of Having your Risk Register in Jira rather than Excel...


Monika Isak
Head of Growth
February 7, 2023
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira...


Marion Lepmets
CEO
November 21, 2022
Comparison between the risk management apps on Atlassian Jira - the SoftComply Risk Manager and the Risk Manager Plus on Jira Cloud...


Marion Lepmets
CEO
November 16, 2022
How to find the best regulatory compliance solution for medtech on Atlassian...