SoftComply Risk Manager is an add-on for Atlassian Jira to manage, trace and report your product risks.
SoftComply Risk Manager Plus is an add-on for Atlassian Jira to manage, trace and report your safety-critical product risks.
SoftComply eQMS is a full medical device Quality Management System developed as an add-on for Atlassian Confluence.
The majority of our clients are in the USA, the UK & the rest of the Europe – they include start-ups as well as Fortune 500 companies.
A Feature That Really Stood Out In SoftComply Risk Manager Was The Risk-Line Duplication Tool, This Helps Speed Up Risk Assessments Significantly!
SoftComply Risk Manager Is Professional, Easily Configurable, Intuitive, And Very Relevant To Risk Management. This Is Probably The Better Of Risk Management Add-Ons For JIRA!
The Traceability Features Of SoftComply Risk Manager Are Great, Giving The Ability To Trace Risk Control Implementation And Mitigation!
SoftComply Risk Manager – Overdue, Highly Useful, Risk Management Add-On For Medical Device Software (And Hardware) Development To The ISO 14971 Standard For Those Using JIRA And Confluence.
I Think SoftComply Risk Manager Would Also Be Suitable For Those Doing Safety Critical Software Development In Other Engineering Domains.
The Automated Risk Management Plan And Risk Management Report Generation Into Confluence Is A Great Feature Of SoftComply Risk Manager, This Should Speed Up Our Risk Documentation!
The Ability To Customise The Risk Matrix & Define Risk Levels In SoftComply Risk Manager Is Great!
Love The Summary Report Being Automatically Included In The Risk Matrix!
Re-Use Is A Big Thing And It Is Awesome That With Your Risk Management Add-On, I Can Reuse Mitigations!
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 […]
Read MoreWhat 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 […]
Read MoreAbstract 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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info@softcomply.com
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Tallinn Office
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