Artificial Intelligence continues to transform healthcare, with AI-enabled medical devices unlocking faster, more accurate diagnostic and therapeutic outputs. From automated image segmentation to abnormality detection and healthcare information summarization, AI solutions are increasingly taking on tasks that were once time-consuming for physicians. As advanced AI techniques continue to emerge, the opportunities for innovation expand exponentially.
However, regulators worldwide are working to keep pace with these rapid technological advances. The regulatory landscape for AI in medical devices remains dynamic and complex, with frameworks in the European Union, United Kingdom, and United States each presenting unique requirements and challenges. Organizations developing AI-enabled medical devices must navigate this evolving environment while ensuring their products meet the highest standards of safety and efficacy.
This comprehensive two-session masterclass addresses these challenges head-on. The first session focuses on developing effective regulatory strategies to maximize the chances of successful submissions across major markets. Participants will explore the documentation requirements specific to AI technologies, learn how to build robust clinical validation frameworks, and understand the standards that govern AI-enabled medical devices.
The second session takes a deep dive into Quality Management Systems, examining how to strengthen QMS frameworks to address the unique requirements of AI development. From data management and software development procedures to post-market surveillance and risk management, participants will gain practical knowledge for building future-proof quality systems.
In this fast-changing regulatory environment, staying abreast of the latest developments is essential for maintaining compliance today and preparing for tomorrow. This masterclass will equip you to stay ahead of regulatory changes and implement robust frameworks that support the safe and effective use of AI in medical devices.
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BY THE END OF THIS TWO-DAY INTENSIVE COURSE, YOU WILL GET:
Identify and differentiate various AI techniques and their regulatory implications for medical device development
Navigate the regulatory frameworks governing AI-enabled medical devices in the EU, UK, and United States
Prepare comprehensive technical documentation that meets requirements beyond standard IEC 62304 for SaMD/SiMD
Develop and implement effective risk management strategies specific to AI technologies
Design clinical validation frameworks appropriate for AI-enabled medical devices
Apply global and regional standards for AI-enabled medical devices to organizational processes
Build data management procedures that address acquisition, testing, and privacy requirements
Evaluate and implement QMS standards that specifically address AI development requirements
Leon Doorn is the CEO & Co-Founder of MedQAIR, bringing over 16 years of experience in regulatory affairs, quality management, and information security within the medical device industry. His extensive expertise spans ISO 13485 and ISO 27001 management systems, as well as MDR, FDA, and Health Canada regulatory requirements, complemented by deep knowledge of GDPR compliance.
Leon specializes in AI-driven medical devices and has developed in-depth knowledge of standards and regulatory expectations for software-based and machine learning-enabled technologies. His unique perspective combines regulatory insight with practical, real-world implementation experience, making complex compliance concepts accessible and actionable.
His training approach is distinguished by its focus on practical application, enabling participants to confidently apply compliance principles in their organizations immediately following the course. Leon's sessions combine theoretical foundations with hands-on guidance, ensuring participants leave with both the knowledge and the tools to navigate the complex landscape of AI-enabled medical device regulation.
