Transforming Medical Device Quality Management
Monidose Oy is a Finnish technology company dedicated to simplifying quality management for medical device manufacturers worldwide.
Our Mission
To empower medical device manufacturers with a comprehensive, user-friendly Quality Management System that ensures regulatory compliance while reducing complexity and costs. We believe that great software should make compliance easier, not harder.
Our Vision
To become the global standard for medical device quality management, helping companies of all sizes bring safe and effective medical devices to patients faster. We envision a world where regulatory compliance enables innovation rather than hindering it.
Our Story
MoniDoseQMS was born from firsthand experience with the challenges of medical device quality management. Our founders, having worked in the medical device industry, understood the pain of managing multiple disconnected tools, struggling with compliance documentation, and spending countless hours on administrative tasks.
We asked ourselves: why should medical device companies need 14+ separate software tools to manage their QMS? Why can't there be one integrated platform that handles everything from document control to post-market surveillance?
That question led to the creation of MoniDoseQMS - a comprehensive platform with 124 integrated modules designed specifically for medical device manufacturers. Today, we're proud to help companies achieve compliance with EU MDR, FDA QSR, ISO 13485, and the EU AI Act.
Our Values
Quality First
We believe in building software that meets the highest standards of quality and compliance.
Transparency
Open communication with our customers and clear documentation of our processes.
Patient Safety
Every feature we build is designed with patient safety as the ultimate goal.
Customer Focus
We work closely with medical device manufacturers to understand their needs.