What is an Electronic Record and How to Manage them in Confluence?
From FDA 21 CFR 11.3(b)(6) “Electronic Record means any combination of text, graphics, data, audio, pictorial,…
Post-Market Surveillance & Risk Management
All product development teams let out a sigh of relief when a product is launched. The…
QMS Essentials for MedTechs in 2025
In this post, rather than talking about Quality Management Systems (QMS) in general, we will go…
Medical Device Compliance Guide for 2025
Introduction This medical device compliance guide focuses on the key requirements and strategies for navigating the…
Navigating FDA Cybersecurity Requirements for Medical Devices – A Case Study
This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity…
Information Security (ISO 27001) Risk Management Best Practices for 2025
Keeping your data safe is vital for every business. One way to do this is by…
Integrate Risk Management in Software Development Lifecycle – Guide for 2024
Integrating risk management into the Software Development Lifecycle (SDLC) of a product is crucial to its…
Hazard Analysis In Jira (Quick Guide)
If your team is working in Jira and you need to conduct hazard analysis, you can…
How to use CVSS in Jira
What is CVSS and when to use it? The Common Vulnerability Scoring System (CVSS) is a…
Don’t Keep a Risk Register in Excel (Use Jira)
If you’re considering using Excel for your risk register, this video explains why that might not…
Jira Risk Management Workflow Tutorial
In this article, we will look at the 4 steps needed to build a Risk Register…
3 Best Jira Risk Register Plugins for 2024
What is a Risk Register and Where to Build It? Risk Management is an essential governance practice…