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 […]
5 Steps to Implement ISO 27001 ISMS in Jira
Information security isn’t optional anymore. Whether you’re handling customer data at a startup or managing intellectual property at a global enterprise, a single security incident can cost you financially, damage your reputation and destroy customer trust. That’s where ISO 27001 comes in. It’s the world’s leading standard for information security management systems (ISMS) and it […]
How to Implement Governance, Risk and Compliance (GRC) Framework in Jira
GRC (Governance, Risk and Compliance) isn’t just corporate bureaucracy – it’s your company’s shield against costly surprises. Too many organizations scramble during audits, struggle with scattered risk registers, and face regulatory nightmares that could be avoided. Watch the full video above to see exactly how to implement GRC and how a pharmaceutical manufacturer did it […]
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 […]
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 […]
Beyond Configuration: How Consultants Empower Regulated Industries
For regulated industries – such as Pharma, MedTech, FinTech and Aviation – compliance isn’t optional; it’s mandatory. Tools like Jira and Confluence are powerful, but their true potential is only realized when configured to meet industry-specific regulatory requirements. This is where industry consultants come into play, offering expertise that goes beyond standard configurations – translating […]
10 Insider Tips from a Notified Body on MDR, AI Act, Audits & Software Tool Validation
If you’re a medical device manufacturer, you already know that compliance isn’t a walk in the park. It’s more like a hike through regulatory terrain with the occasional mountain lion (metaphorically speaking). But don’t panic. We’ve distilled insights from a recent expert-packed webinar to help you navigate the wild world of EU regulations – with […]
How to do FMEA for Medical Devices: Step-by-Step Guide to Risk Management
In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact patient health and wellbeing. If you operate within the medical device industry as a manufacturer, Software as a Medical Device (SaMD) developer, OEM supplier or […]
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 […]
