Artificial Intelligence (EU AI Act, FDA) Training
Learn regulatory frameworks for AI-enabled medical devices, ensuring compliance with EU AI Act and FDA guidelines.
Overview
Artificial Intelligence (AI) is reshaping the medical device industry, offering groundbreaking solutions for diagnosis, treatment, and patient care. However, these advancements come with complex regulatory challenges. Our Artificial Intelligence (EU AI Act, FDA) Training is designed to equip professionals with the knowledge and skills needed to navigate these evolving regulatory landscapes. This program emphasises data governance and risk management within the EU AI Act and FDA frameworks, ensuring regulatory compliance for AI-enabled medical devices
Benefits of Attending
- Gain a comprehensive understanding of the EU AI Act and FDA regulatory frameworks for AI-enabled medical devices.
- Learn practical strategies for implementing compliance measures, including risk management and bias mitigation.
- Understand key concepts like Predetermined Change Control Plans (PCCPs), post-market monitoring, and data governance.
- Stay ahead of regulatory deadlines, such as the EU AI Act’s enforcement starting August 2026.
- Enhance your ability to integrate AI technologies into medical devices while ensuring safety, efficacy, and transparency.
Who Should Attend?
This training is ideal for:
- Regulatory affairs professionals working in the medical device industry.
- Quality assurance specialists responsible for compliance with global standards.
- Engineers and developers of AI-enabled medical devices seeking to understand regulatory requirements.
- Healthcare professionals interested in the ethical and practical implications of AI in clinical practice.
- Business leaders aiming to align their organisations with upcoming regulatory changes.
Comprehensive, Expert-Led Training Hub
Gain industry-leading insights with structured, interactive courses designed to simplify regulations, enhance compliance, and drive industry best practices.
