7. Artificial Intelligence, Software & Digital Health

Artificial intelligence, machine learning, and digital health technologies create new opportunities in diagnostics, therapy, and clinical decision support.

At the same time, these technologies introduce specific requirements concerning data quality, algorithmic performance, transparency, software validation, risk management, and control of product changes.

Avary Consulting supports companies in regulatory assessments and the development of appropriate compliance strategies for AI-based medical devices and Software as a Medical Device (SaMD).

Our approach considers the applicable requirements of the MDR, IVDR, and Regulation (EU) 2024/1689 (EU AI Act), including their transitional provisions and implementation timelines.

For the U.S. market, we incorporate relevant FDA requirements and guidance concerning AI-enabled medical devices.

We also consider applicable standards such as IEC 62304 for software lifecycle processes, ISO 14971 for risk management, and ISO/IEC 42001 for AI management systems.

Our services include:

• Regulatory classification and strategy development
• Assessment of regulatory requirements for AI-based systems
• Support for software and algorithm validation
• Evaluation of data quality and performance evidence
• Integration of risk management and technical documentation
• Support for software and model change management strategies
• Regulatory gap assessments for digital medical devices

Our Recommendation for Companies: Develop regulatory strategy, data management, risk management, and validation concepts together. Particularly for AI-based products, subsequent model changes may significantly affect the regulatory assessment.