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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Six Must-Have Atlassian Cloud Apps for the Regulated Industries

With Atlassian’s Server end of life approaching in a few years, most companies need to decide whether to migrate to Cloud or to Data Center. Data Center may seem like a natural path to take for the larger (over 300 users) companies in the regulated domains. Nevertheless, there are some regulated industries like the medtech […]

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How to Manage Requirements in Confluence and Jira

Requirements management in the regulated domains such as medtech, automotive or aviation has certain differences compared to the agile development. Jira Software with its easy to use backlog view and work boards suits best for managing requirements in the agile world. For the regulated domains it might be better to use Confluence in addition to […]

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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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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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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 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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