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 […]
AI-enabled Medical Devices – FDA Guidance
Intro Medical Devices that contain AI-driven functions have been the focus of Regulatory Agencies in both the EU and the US for the past 2 years, with the FDA taking the lead in releasing regulations and guidance on the matter. On January 6, 2025 the FDA released a new Draft Guidance “Artificial Intelligence-Enabled Device Software Functions: […]
ISO 13485 Implementation Guide for Startups in 2025
The Internet is full of articles about the implementation of ISO 13485. They talk about “Getting management support”, “Obtain The Documents And Study The Requirements”, “Develop An Implementation Plan”, “Evolution of a Quality Management System”, and other seemingly complex topics. Although comprehensive, most of these articles are self-serving, aimed at promoting specific services of the […]
Software as a Medical Device (SaMD) Startup Guide to Compliance for 2025
Introduction The first contact with the Medical Device regulatory world is a shock for most startups. These companies usually have excellent technical and clinical ideas on how to improve the patient’s life, but little knowledge of the legal burdens required to bring the medical device to the market. The technical world of reasonable certainties clashes […]
18 e-Signature Apps in Confluence Cloud (Comparison for 2025)
What is an “Electronic Signature”? Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. (21 CFR 11.3) In other words, to Electronically Sign a document means to execute of a series of […]
How a Compliance Solution on Atlassian Cloud Empowered a Leading MedTech Company
A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the existing ways of managing risks and documentation – such as Excel spreadsheets and paper-based processes – became increasingly inefficient and error-prone. This not only […]
