Marion Lepmets _SoftComply_ Community Champion

You are kindly invited to join our webinar on Validation & a live demo of our automated validation testing app for Confluence Cloud: https://us02web.zoom.us/webinar/register/WN_sR2Awbg6RR-spFl2UgGEZw

You are kindly invited to join our webinar and live demo next week on Risk Management on Atlassian Cloud - how to manage, trace and report risks in Jira and Confluence: https://us02web.zoom.us/webinar/register/WN_GQv3lbEnSq6ECrhx50suCA

Introduction The SoftComply Risk Manager Plus app on Jira Cloud supports different risk management methods across various domains. With the SoftComply Risk Manager Plus app, you can: * build global Risk Model and Risk Table Templates & assign them to your existing Jira projects for your risk management purposes; * build 2-…

Modern medical device regulations are putting more and more emphasis on the management of software tools. These tools are software packages that are not part of the medical devices themselves, but support the device during its development lifecycle and quality management. Confluence Cloud is one such software tool that…

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…

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…

This webinar describes the Best Practices of Managing your Quality System and Risks on Atlassian Jira and Confluence Cloud. This 1hour webinar focuses on how to best manage documents, records, risks and report risks using Jira and Confluence in combination with Atlassian apps for compliance. Join us on Thursday, March 9th…

We get it, the traditional Risk Management process is an essential governance practice for product, portfolio, and project management. For many of us, the Risk Register is still stuck in a MS Excel spreadsheet that someone like the Project Coordinator or the Risk Manager tries to keep updated. Here are 4 reasons that will…

Most regulated industries are required to validate their software tools. These tools are software packages that support the product development lifecycle and quality management. Nowadays companies use dozens of applications, ranging from accounting tools to email clients to software compilers. Of course not all of them…

Managing your device/product risks in Jira is great – you can use the flexibility of Jira to add various fields to the risk table, customise the risk table and the risk matrices and filter/sort the data any which way you want when using the SoftComply Risk Manager app on Jira. But what if you’d like to report your risks in…

SoftComply has developed a compliant risk management add-on for Jira, specifically for safety-critical software development. This risk management add-on is configurable to any product risk management method/approach while being fully compliant with the requirements of ISO 14971, the medical device risk management standard.…