How to Customize your Product Risk Matrix in Atlassian Jira

With SoftComply Risk Manager , you will work with a fully customizable Risk Matrix to identify, evaluate, mitigate and verify your product risks. SoftComply Risk Manager automatically generates Risk Matrices and Risk Reports! SoftComply Risk Manager is an add-on for Atlassian Jira – try it out for free for a month from Atlassian Marketplace. Short […]

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FME(C)A or FMEA?

FMEA or FMECA? Criticality or not? Which one is better? Which one should you use? The answer is simple: it depends. You are probably fed up with the “it depends” answers you get in this sector. But in this case it means “It depends on YOU”. First the compliance bit: there is no requirement, in […]

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4 Challenges of Safety Critical Software Development

When someone’s life is in your hands, you are going to be very careful with it. That’s why the safety-critical software used in aviation systems, automotive, traffic signals, or medical devices has always relied on highly-structured software development methods like waterfall. With a heavy emphasis on design review and testing, these methods are naturally quite […]

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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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How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA

Part II By Matteo Gubellini, VP of Regulatory Affairs at SoftComply* So you are looking for a Risk Management tool? Something easy to use, with good traceability features? There is plenty out in the market to pick from. All of them good tools, that tick all the boxes. I have been there several times, both […]

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How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA

Part I By Matteo Gubellini, VP of Regulatory Affairs of SoftComply* “Ok, let’s follow a few of these risk mitigation actions down to outputs and verification activities” says the auditor. Typical question. Actually there couldn’t be a more typical audit question. Traceability. We have been here dozens of times. And every time it’s the same […]

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