SoftComply Risk Manager is now Cloud Fortified

Last week we reached an important milestone – the SoftComply Risk Manager on Jira Cloud was awarded the Cloud Fortified badge by Atlassian. The SoftComply Risk Manager is the only product risk management app on Jira and the most customisable one with Risk Management guidance, multiple views to work in and compliant Risk Reporting. To learn more about the SoftComply Risk Manager […]

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How to Create a Risk Traceability Matrix in Jira

Risk Traceability is a great way to get a quick overview of the completeness of risk management process and it is often used in the regulated industries. The traceability matrix shows the coverage of risks by mitigation and verification actions. For example, in the medical device industry, both the FDA and ISO 14971 require bi-directional […]

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How to Create a Risk from Jira Support Ticket?

Jira is the most flexible task management tool there is. No wonder that more than 200’000 companies across the world have found it useful. It helps software teams build their products, prioritise their backlog and manage any upcoming issues within their team. Most of these companies are using Jira Service Management to collect customer feedback […]

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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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How to Report Risks in Confluence

Managing your product risks in Jira is great – you can use the flexibility of Jira to add various fields to the risk table, customise the risk table and the risk matrices and filter/sort the data any which way you want when using the SoftComply Risk Manager app on Jira.  But what if you’d like to report your risks […]

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Risk Management Guide for a Digital Health or a Medical Device Company on Jira Cloud

Why Risk Management Compliant Risk Management is a mandatory regulatory requirement for companies in medical device and other safety-critical domains. It is a specific aspect of safety-critical system development that requires linking risks to system/software design and testing to ensure the system is safe to use. Various standalone solutions exist today for safety-critical system developers […]

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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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Compliance of myBioma

The Regulatory Compliance Journey of myBioma Biome Diagnostics GmbH is an Austrian medtech start-up utilizing the genetic information of the microbiome and AI to develop medical diagnostic software for doctors. Biome Dx products utilize technologies such as next-generation sequencing, pipeline architectures and microservices. With their lifestyle product myBioma every European has the possibility to learn […]

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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 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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