Why Medical Device Startups Need Electronic Document Management Systems (And How to Build One in Confluence)
If you’re developing a medical device, you must prove that it is safe and effective. That proof lives in your documents: your procedures, design records, risk assessments, and test reports. Managing those documents properly is called “document control”. At first, this might sound like an administrative detail — a few folders, some version naming, maybe […]
Why Document Control Can Make or Break Your Regulated Business (and how SoftComply can help)
Picture this: You have just finished writing your requirements specification and saved it as “Requirements_final.doc” Then come the edits, code reviews, and compliance feedback. Suddenly you’re looking at three files: “Requirements_final_v2.doc”, “Requirements_final_really_final.doc”, and “Requirements_fixed_final.doc”. Which one’s actually the final one? You send one to the team, but they build from another. Suddenly, the project’s out […]
Inside the 4th Compliance Alliance Workshop: Building Trust and Compliance on Atlassian Cloud
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 must-have compliance solutions to Atlassian […]
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 […]
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 Automate Confluence Cloud Validation for Medical Device Companies
Medical device companies face a constant challenge: how do you validate cloud software tools that update daily? If you’re using Confluence Cloud for your quality management system, you need validation documentation that keeps pace with Atlassian’s frequent updates. I’ll walk you through exactly how to automate this process using the SoftComply Validation for Confluence Cloud […]
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 […]
Complete Guide to Medical Device Hazard Analysis based on ISO 14971 and IEC 62304
Medical device risk management isn’t just another regulatory checkbox. It’s the foundation that proves your device is safe for patients and users. When auditors come knocking, they’ll scrutinize your risk management process more than almost anything else. Get it wrong and you’re looking at serious compliance issues. I’ve put together this comprehensive guide to walk […]
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 […]
