How to Manage Organizational Risks with ISO 31000 in Jira
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. That’s where ISO 31000 comes […]
How to Set Up RAID Project Management in Jira: A Complete Guide
Project managers know that uncertainty is the enemy of successful delivery. You’ve got potential risks lurking around every corner, assumptions that might prove wrong, current issues demanding attention and dependencies that could slip at any moment. This is where RAID comes in (and no, I’m not talking about the data storage kind). Watch the full […]
How to Create Risk Reports in Jira and Confluence
Risk reporting isn’t just another checkbox on your compliance list. It’s the backbone of effective risk management that keeps your team informed, your management happy, and your auditors satisfied. When you’re managing risks in Jira, you need clear, current reports that don’t require endless manual updates or screenshot juggling. Watch this video to see exactly […]
How to Implement P1 and P2 Hazard Analysis in Jira for Medical Devices
Do you want to make your medical device risk management more precise? While many companies stick with single probability values in their hazard analysis, ISO 14971 suggests breaking down probability into P1 and P2 components. I’ll show you exactly how to set this up in Jira using nested risk models. Watch the video above to […]
Medical Device FMEA: 10 Steps to Bulletproof Risk Management
Risk management in the medical device industry isn’t optional – it’s literally life or death. If you’re developing medical devices, you need to identify, assess, and mitigate risks throughout your entire product lifecycle. Patient safety depends on it. Watch this step-by-step guide to implementing FMEA for medical device risk management. Last week I covered hazard […]
6 Steps to Agile Risk Management Success in Jira for Regulated Environments
Balancing agile development with regulatory compliance feels like trying to mix oil and water. But what if I told you there’s a way to integrate risk management directly into your Jira workflow without sacrificing speed or compliance? Based on a recent webinar with Aaron Morris, I’ve distilled the process into six practical steps that will […]
Risk Management Software: Buyer’s Guide for 2025
INTRODUCTION If you are a risk management professional or business owner, you understand that organizations today face a complex risk landscape driven by technological advancements, evolving regulatory frameworks, and globalization. Developments in AI, cloud computing, and IoT have introduced significant risks, with cybercriminals using these same tools to launch more sophisticated attacks. According to the […]
The Ultimate Guide to ISO 14971 Risk Management
Who Is This Guide For? At SoftComply, we understand the importance of proper risk management. From costly design changes to product recalls and bad press, not accounting for risks is in fact the single biggest gamble that companies are taking today. If you are a medical device manufacturer, marketer, designer, or anyone connected with the […]
