We are proud to announce the release of our latest white paper

ISO 42001:2023 and Its Role in AI-Driven Medical Device Ecosystems

As AI continues to transform the medical device industry, regulatory frameworks must evolve to ensure transparency, fairness, and security. ISO 42001:2023 is the first global standard dedicated to governing Artificial Intelligence Management Systems (AIMS), setting clear guidelines for ethical AI, risk management, and regulatory compliance.

What’s Inside

  • Core principles of ISO 42001

    including human oversight, bias mitigation, and AI transparency

  • Integration with other ISO standards

    such as ISO 13485, ISO 14971, and ISO 27001 for a comprehensive regulatory approach

  • AI risk management strategies

    bridging traditional medical device risks with AI-specific challenges

  • Implementation roadmap

    to help manufacturers align their AI-driven devices with regulatory expectations

If you’re working with AI in medical devices, this white paper is a must-read. It provides a clear understanding of how AI impacts regulatory and compliance requirements and offers practical steps to ensure your AI-driven technologies meet the latest global standards. Stay ahead of evolving regulations and secure a competitive edge in AI-powered healthcare.


Download the White Paper

Download now and take a proactive approach to AI governance in medical devices!

Partner with confinis

At confinis, we provide expert guidance to help medical device manufacturers navigate the evolving regulatory landscape. Get in touch with us today to ensure compliance and innovation go hand in hand.