Periodic Document Reviews in Confluence Cloud: Why They Matter to MedTech
Your procedure is approved. But does it still describe how your team should work? Since its release, you may have changed your development tools, introduced a new supplier or reassigned responsibilities. Findings from a complaint investigation may have highlighted a gap in your processes. Your development team may have outgrown the current process and needs […]
How to Review and Approve AI-Generated Confluence Pages with SoftComply Document Manager
AI can draft a procedure in seconds. Before anyone follows it however, a person still needs to check that it describes the right process, uses current sources and has been approved for use. In regulated organisations, documents guide work and provide evidence of decisions. Outdated instructions or unsupported claims can have consequences long after the […]
Best E-Signature Apps for Confluence Cloud (2026 Buyer’s Guide for Regulated Industries)
Not every Confluence e-signature app is designed for regulated industries. This guide explains how to evaluate Atlassian Marketplace apps against 21 CFR Part 11 and choose the right solution for MedTech, pharma, and biotech teams. Looking for an E-Signature App for Confluence? Open the Atlassian Marketplace and search for electronic signatures. You’ll find approval apps. […]
How to Build a Living GRC System in Jira and Confluence
Welcome to the wondrous world of GRC! Don’t worry, you’re not alone if GRC sounds like a magic spell from “Harry Potter.” For most of us, Governance, Risk, and Compliance (GRC) is one of those terms that sounds important in meetings, like when someone mentions “synergy.” But the truth is, GRC means different things in […]
Achieving CE Mark Faster: Amiko’s Story of Agile Compliance with a Confluence-Based Document Management System
We recently sat down with Elisa Lo Blanco, Quality Assurance and Regulatory Affairs Manager at Amiko, a digital health company focused on chronic respiratory conditions, to discuss their journey to achieving CE marking under the Medical Device Regulation (MDR). Amiko’s success highlights how MedTech startups can balance the need for regulatory rigor with the flexibility […]
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 […]
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 […]
What does FDA Guidance on Predetermined Change Control Plan mean for Medical Device Manufacturers?
Intro FDA aims to provide a regulatory framework that supports innovation in medical device software development. As such, they understand the need to rapidly change and update software without affecting the safety and effectiveness of the device. In such cases, a new submission shouldn’t always required. But when? Overview In August 2024 the FDA release […]
