Regulatory Compliance on Atlassian
for FDA approval & CE-marking

Risk Management on Jira
for Software Products

Quality Management on Confluence
for Medical Devices

Products

Looking for Software Product Risk Management on Jira?

SoftComply Risk Manager is an add-on for Atlassian Jira to manage, trace and report your product risks.

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Looking for Safety-Critical Product Risk Management on Jira?

SoftComply Risk Manager Plus is an add-on for Atlassian Jira to manage, trace and report your safety-critical product risks.

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Looking for a compliant medical device Quality Management System on Confluence?

SoftComply eQMS is a full medical device Quality Management System developed as an add-on for Atlassian Confluence.

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SoftComply products are used by 255 companies

What our clients say about us

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!

Some of our customers

Our partners and supporters

Latest blog posts

How to Manage Safety-Critical Product Risks in Jira – New Features of SoftComply Risk Manager and Risk Manager Plus

22 Aug 2019

Risk management is a regulatory requirement for safety-critical products. Without compliant risk management most of these products cannot reach their users. With more and more software in safety critical products like medical devices or cars, software developers now also have to manage the risks during the development to ensure the safety of these products. The […]

How to Set Page Level Restrictions in Confluence?

15 Jul 2019

In our previous blog posts we have described the Confluence Server level access and Space access and will focus on page level restrictions in this blog post. You can get lots of benefits while knowing a few simple tricks about page restrictions. What are page restrictions and why should I use it? According to Atlassian, […]

How to Secure your Documents in Confluence?

24 Jun 2019

This short post will provide you insight into taking control over your document management in Confluence Server. This post is not going to touch regular security policies like VPN, firewalls, security policies and ohter things that are outside of the Confluence Server. In other words, all the really technical things are left out and we […]