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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Comparison of SoftComply eQMS & MediCompli Solution

What is a Quality Management System? You probably know that Medical Device companies are required to have a Quality System in place, in order to be able to market their products in most countries in the world. This Quality System, or Quality Management System – QMS, is a collation of Procedures, documents, templates and records […]

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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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