New in SoftComply Risk Manager on Jira Cloud

In addition to being able to apply the SoftComply Risk Manager to any Jira projects – the new feature of the Risk Manager on Jira Cloud we released in December 2020, there are another two new features we released just now. NEW RISK PROJECT CREATION WIZARD When you are creating a new risk project with […]

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How to apply SoftComply Risk Manager features to any Jira project

Wouldn’t it be cool to keep everything in Jira – your backlog, your test cases and your risks all in Jira? Yes, but you could do that for years already. But what if all that can be done in a single Jira project? That would be truly awesome! You can now do it with the […]

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Why Decompose the Probability of Harm in two – P1 and P2

P1 and P2 No we are not talking about the early Playstation versions… ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where: P1 = Probability of Hazardous situation occurring P2 = Probability of Harm occurring for a given Hazardous situation […]

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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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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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SoftComply offers Free Apps to get More Ventilators and Test Kits for COVID-19 to Market Faster

Medical equipment at the Columbus Covid-2 Hospital, in Rome, on March 16, 2020 from The Globe and Mail With the lack of medical equipment in light of the rapid spread of COVID-19 and the hospitalization of infected people (1), SoftComply offers their support to medical device companies. Medical device companies are currently working non-stop to […]

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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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