Six Must-Have Atlassian Apps for MedTech Companies

Which tools should I pick from the Atlassian stack? Jira? Jira Software? Jira Core? And then there is a marketplace full of apps that sit on Jira and Confluence. Can I pick one from there or do I need apps at all? These and many similar questions are asked by almost all new Atlassian users […]

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Cybersecurity in Medical Devices

As software is becoming more and more integral to Medical Devices, new opportunities arise from their networking and data exchange. But this is also exposing them to the same risks as common objects such as laptops and smartphones, i.e. unauthorized access to the device. Although the FDA “is not aware of any patient injuries or […]

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How to Set Jira Notifications for Risk Management? Must-Have Tips for Risk Managers!

As you probably know by now Jira is the most customizable issue and project tracking software on the market. It is so flexible, in fact, that sometimes a simple feature might be forgotten or some things are not always easy to find. Today we will explain and provide practical tips on how to set and […]

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How to Manage Safety-Critical Product Risks in Jira – New Features of SoftComply Risk Manager and Risk Manager Plus

Risk management is a regulatory requirement for safety-critical products. Without compliant risk management most of these products cannot reach their users. With more and more software in safety critical products like medical devices or cars, software developers now also have to manage the risks during the development to ensure the safety of these products. The […]

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IEC 60601 – Essential Performance, Safety and Risk Management

IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. Although if focuses primarily on electromechanical devices, it also applies to aspects of the software components. It is a widely recognized standard that most, if not all, medical device companies have to comply with. The concept of […]

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