Artificial Intelligence, Digital Health & Regulatory Compliance
Artificial Intelligence, Digital Health & Regulatory Compliance
Implementing Emerging Technologies Responsibly and with Regulatory Confidence
Artificial intelligence and digital technologies are transforming the development, manufacturing, and application of medical products.
These technologies introduce new requirements concerning regulatory assessment, data quality, transparency, safety, performance, and lifecycle management.
Our training programs provide regulatory and methodological foundations for implementing AI in regulated product environments.
Key Training Topics:
- Fundamentals of regulatory requirements for AI-based medical devices
- Software as a Medical Device (SaMD)
- EU Artificial Intelligence Act – Regulation (EU) 2024/1689
- Interaction between the EU AI Act, MDR, and IVDR
- Risk management and regulatory documentation
- Software lifecycle processes according to IEC 62304
- AI management systems according to ISO/IEC 42001
- Data quality, verification, validation, and algorithmic changes
- Relevant FDA guidance concerning AI-enabled medical devices
Our training content considers applicable implementation dates and transitional provisions of European and international regulatory frameworks.
Value for Your Organization: Earlier identification of regulatory risks, improved planning of AI-related projects, and better-informed decisions in digital health product development.