Hazard Analysis & FME(C)A on Jira – SoftComply Risk Manager PLUS is out now!

November 2, 2018

We are happy to inform you that our Risk Management solution for Jira has gotten an upgrade for Jira Server users – the SoftComply Risk Manager Plus focusing specifically on safety-critical product/device/system risks.

SoftComply Risk Manager Plus supports both Hazard Analysis as well as FME(C)A, including FME(C)A with Detectability and RPN (Risk Prioritization Number).

Although ISO 14971 requires only to identify and analyze hazards, thus suggesting a Top-Down approach, it is a best practice among safety-critical system developers to complement it with a Bottom-Up analysis, i.e. a FME(C)A.

The purpose of this combined approach is to ensure all risks and faults are captured during the analysis. The two approaches will have many scenarios in common, but this redundancy will also provide additional failures that may have been missed using only one method.

Learn more about the features of the SoftComply Risk Manager PLUS or contact us for a demo.

Table of Contents

Ready to get started?

Contact us to book a demo and learn how SoftComply can cover all your needs

Compliance Workshop cover page
Picture of Marion Lepmets

Marion Lepmets

CEO
October 15, 2025

During Atlassian Team25 Europe, the Compliance Alliance hosted the 4th Compliance Workshop in Barcelona. Despite a wild thunderstorm, nearly 30 compliance enthusiasts braved the rain to join the workshop – a session packed with insights on AI in regulated industries, Atlassian Isolated Cloud, Cybersecurity of Marketplace Cloud apps, and selling...

Vendor Security Risk Assessment in Jira
Picture of Marion Lepmets

Marion Lepmets

CEO
October 1, 2025

Every company depends on others to survive. From your cloud provider to your payroll processor, your business is connected to a web of vendors. But here’s the reality: over 60% of data breaches originate from third-party vendors. This is why managing your vendor security risks has become more important than...

31000
Picture of Marion Lepmets

Marion Lepmets

CEO
September 22, 2025

Most companies have informal risk discussions in meetings. You know the type – “What happens if our lead developer leaves?” or “What if this big deal doesn’t close?”. These conversations usually end without any real action plan and you find yourself talking about the same risks over and over again....