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

FDA’s Comprehensive Draft Guidance for AI in Healthcare.

As Artificial Intelligence (AI) transforms healthcare, understanding the evolving regulatory landscape is critical. This white paper provides a deep dive into the FDA’s latest draft guidance documents, highlighting key frameworks for ensuring the safety, effectiveness, and transparency of AI-enabled devices and applications in healthcare.

What’s Inside

  • Overview

    of the FDA’s draft guidance documents, including Predetermined Change Control Plans (PCCP) and lifecycle management for AI-enabled devices

  • Insights

    into integrating Good Machine Learning Practice (GMLP)

  • Implications

    for manufacturers, regulators, and healthcare providers

  • Strategies

    for managing updates, data bias, and model transparency

Whether you’re a manufacturer, regulatory professional, or quality manager, this white paper is a must-read to ensure your processes align with the latest regulatory standards.


Download the White Paper

Download now to stay informed and navigate the complexities of AI regulatory compliance with confidence!

Partner with confinis

At confinis, we specialize in guiding medical device manufacturers through the intricacies of regulatory compliance. Get in touch with us today for tailored support on AI-enabled devices and beyond.