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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Building Medical Software Compliance on Atlassian Tools

What is Atlassian Summit? The biggest annual event of Atlassian will take place next week with hundreds of Atlassian users and developers descending to San Jose to listen to the success story of one of the fastest growing enterprise software technologies today. Their high-velocity distribution model drives an exceptional customer scale by making affordable products […]

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Building regulatory compliance into the software development life cycle

Safety is the central concern for medical device software development and the development of safe systems is rigorously supported by various regulatory requirements focusing on development process compliance. In other words, a strong emphasis is placed on regulatory oversight and device approval before market release to ensure proper verification and validation of these devices. Due […]

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What is software risk management in safety-critical domains?

In the Medical Device market, safety is defined as freedom from unacceptable risk. Even regulatory agencies acknowledge that there is no such thing as a risk-free medical device. Medical device manufacturers have to aim for safer medical devices which, in turn, result in fewer device recalls. Risk Management is the process by which software risks […]

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The worlds of software development and medical devices could not be further apart

Software development is agile, fast and innovative, while medical device development is often slow, reactive and change adverse. SoftComply has developed a set of tools which will help your company comply with the regulatory requirements with the minimum effort and get your innovative medical devices to market faster. Numerous software companies struggle to enter medical […]

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