While agentic AI introduces a new approach to risk and compliance, implementing this innovation is not problem-free.

Employing a risk-based approach, the act imposes the most stringent rules on high-sensitivity AI systems, e.g., those used in healthcare and critical infrastructure, while low-risk applications ...

Across the globe, frameworks such as the EU AI Act, ISO 13485 combined ... and ethical implications. AI-based medical devices (AIMD) are classified as "high-risk," requiring a CE mark and ...