Elevating Quality and Compliance into the Future of AI
Introducing Our AI Compliance Services
As Artificial Intelligence becomes increasingly embedded in medical technologies, ensuring responsible and compliant AI system management is no longer optional—it’s essential. At confinis, we guide our clients through this evolving regulatory landscape with expertise, clarity, and a strategic mindset.
Just as we’ve transformed traditional quality systems with our electronic Quality Management System (eQMS) based on Atlassian platforms, we now bring the same innovation-driven approach to ISO/IEC 42001 compliance—the first international standard for AI management systems.
This standard enables organizations to establish, implement, maintain, and continually improve an Artificial Intelligence Management System (AIMS). Our role? To be your strategic partner in navigating this complex terrain, ensuring your AI systems are trustworthy, transparent, and compliant.
Our ISO/IEC 42001 Services Include
Why Choose confinis?
At confinis, we understand that AI in healthcare is not just a technical innovation—it’s a responsibility. Our approach blends deep regulatory insight with agile execution, allowing you to embed AI responsibly within your medical devices, diagnostics, or combination products.
Just as we’ve pioneered paperless quality systems, we now help you shape a sustainable, ethical, and globally aligned AI future.
Let’s Shape the Future of Healthcare Together
Whether you’re developing an AI-powered diagnostic tool or integrating machine learning into medical device workflows, confinis helps you implement ISO/IEC 42001 as part of a robust, future-ready compliance strategy.
Contact us today to learn how we can support your AI compliance journey.
