How to Manage Software Risks in Jira?

Perhaps the question we should ask first is: WHY MANAGE RISKS IN JIRA? A growing number of software product companies in the world are already using Atlassian tools and enjoying the seamless integration between project and document management with easy tracking and monitoring of their work. More and more companies are ready to abandon standalone […]

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Book Review of “Risk: Why Smart People Have Dumb Accidents”

Book review of Steve Casner’s Risk: why smart people have dumb accidents – and what we can learn from them

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How to Build a Risk Analysis in Jira

How to build a risk analysis in Jira with the SoftComply Risk Manager app

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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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What are the best Risk Management Apps on Jira & how they compare to each other?

In the following post we compare the features of 4 top risk management apps on Jira Server. Comparison of risk management apps on Jira Cloud can be viewed here. There are four popular apps on Jira Server for risk management purposes. Two of them are for product risk management and the other two for project […]

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Afraid of the new MDRs?

By Matteo Gubellini, Chief Regulatory Officer at SoftComply Who’s afraid of the MDRs and the new approach to risk management in the EU? Well, everyone! The new and scary regulations for medical devices in the European Union will be made effective towards the end of this month. Driven by the necessity of updating an old […]

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What is a Risk/Benefit Analysis & How To Do It?

The Risk / Benefit analysis is one of the most misinterpreted areas of the Risk Management process. And consequently one of the preferred digging points for the Notified Bodies. The spirit of the regulations and standards is “the benefit provided by the use of the device must outweigh the associated risk”. That sounds simple doesn’t […]

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Risk Management – part of a Quality Management System?

Risk Management is a key and mandatory part of a medical device development process. Unfortunately, Risk Management is often treated as merely an exercise required to achieve compliance rather than a tool to achieve an optimum design and to ensure the safety of the medical device. Let’s see how to get the best out of […]

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What is FMEA and how is it different from Hazard Analysis?

From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an inductive technique using the question “What happens if … ?”. Components are analysed one at a time, thus generally looking at a single-fault condition. This is done in a “bottom-up” mode, […]

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New Medical Devices Regulation & Risk Management

The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]

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What is FMEA and when to use RPN?

Per ISO 14971, “Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis (FMECA) are techniques by which an effect or consequences of individual components are systematically identified and is more appropriate as the design matures.” We won’t go into the details of the FMEA, but often we were asked to explain when (and […]

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SoftComply Risk Manager for Atlassian JIRA Cloud users now available!

SoftComply is pleased to announce that the first add-on for product risk management for JIRA Cloud users has arrived. SoftComply Risk Manager is a fully customizable risk management tool allowing users to identify, manage, mitigate, verify, trace and report product risks. Developed specifically for the needs of safety-critical product risk management, SoftComply Risk Manager provides […]

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