3 MUST-HAVE AREAS TO CONSIDER WHEN SETTING YOUR ORGANIZATION UP ON ATLASSIAN STACK

3 things regulated industries must consider when setting up their organisations on Atlassian Jira and Confluence

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Top 3 Features of an Electronic Document Management System for Medical Devices

As all the rest of your work has moved from manual to electronic, your Document Management System (DMS) should also be fully electronic. Preferably on the same platform you are using for the rest of your medical device development related work. For example, if your software development team is using Jira, it is only natural […]

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Medical Device Compliance & Atlassian Cloud

On the 16th of October 2020, Atlassian announced radical changes to their offering. From February 2nd 2021, Atlassian will not sell any new Server licenses for any of their products. A year later, in February 2022, it will not be possible to upgrade or downgrade your Atlassian Server product tier. From February 2023, it will […]

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Compliant PPE Production

The Regulatory Compliance Journey of XRGO Nathaniel Victor, CEO of XRGO: “We got involved in PPE manufacturing as a goodwill donation/gesture of time, energy, products and financial support to the hospitals and local municipalities. Early on, our suppliers in China informed us that COVID-19 was serious and they advised that we protect our staff and […]

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How the MediCompli Solution helped Cibiltech become FDA 21 CFR 11 Compliant on Atlassian Confluence

Customer Story on the MediCompli Solution at Cibiltech Cibiltech Cibiltech is a French medical device company developing an AI based personalized medicine solution for better patient care. Their most recent solution is aimed at post-transplant kidney monitoring for personalized treatment and better decision support.   Previous Document Management System at Cibiltech Prior to the MediCompli […]

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How to Turn Confluence into a Compliant Document Management System for Medical Devices

WHY CONFLUENCE? Most medical device companies need to have at least a compliant quality management system in place, not to mention the quality records that will always need to be generated during the lifecycle of the device. With your software development team using Jira, it is natural that your organisation would like to have everything […]

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What is a Risk Management File?

ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]

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How to Create an Organisational Risk Register with SoftComply Risk Manager?

Abstract The aim of this blog post is to guide you through the creation of an organisation-wide Risk Register with SoftComply Risk Manager. This Risk Register supports risk management across your organisation providing your team members with a list of risks that apply to a specific product or project. To achieve that, we will first […]

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Comparison of Risk Management Apps on Jira Cloud

Following our previous post where we compared the 4 top risk management apps on Jira Server, in this post we are comparing the features of the 2 most popular risk management apps on Jira Cloud. One of them is for product and project risk management (SoftComply Risk Manager) and the other for organisational risk management (Risk […]

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