Artificial intelligence introduces new challenges for medical device manufacturers, from ensuring data quality and traceability to managing AI-specific risks throughout the product lifecycle. This solution pack brings together key standards and guidance to help you establish robust data management practices, assess the impact of AI systems and address the unique risks associated with machine learning and AI-enabled medical devices.
By combining guidance on data management, risk management and AI impact assessment, this pack supports the development of safe, effective and trustworthy AI-enabled medical devices, while helping you demonstrate regulatory readiness and stakeholder confidence.
What's included?
PD IEC PAS 63621:2026 – Artificial intelligence enabled medical devices. Data management.
Provides guidance on managing data throughout the lifecycle of AI-enabled medical devices. It covers data quality, representativeness, traceability, governance and documentation to support the development of reliable and trustworthy AI systems used in healthcare.
PD CEN ISO/TS 24971-2:2026 – Medical devices. Guidance on the application of ISO 14971. Machine learning in artificial intelligence
Offers practical guidance on applying medical device risk management principles to AI and machine learning technologies. It helps organizations identify, assess and control risks associated with training data, model performance, algorithm updates and unintended outcomes.
BS EN ISO/IEC 23894:2024 – Information technology. Artificial intelligence. Guidance on risk management
Provides a framework for managing AI-related risks across the entire AI lifecycle. It helps organizations identify AI-specific hazards, evaluate potential impacts and implement appropriate controls to improve trustworthiness, safety and governance,
BS ISO/IEC 42005:2025 – Information technology. Artificial intelligence (AI). AI system impact assessment
Guides organizations in assessing the broader impacts of AI systems on individuals, society and business operations. It supports informed decision-making by helping teams evaluate ethical, social, legal and operational considerations throughout the AI lifecycle.
Who is this pack for?
- Medical device manufacturers
- AI developers and data scientists
- Risk management teams
- Regulatory affairs professionals
- Performance evaluation and clinical teams responsible for AI-enabled devices.
Why should you use this solution pack?
AI-enabled medical devices depend on high-quality data, effective risk controls and a clear understanding of the potential impacts of AI systems. This solution pack provides a practical framework to help organizations manage AI throughout the product lifecycle, from data collection and model development to deployment and post-market monitoring.
It helps you to:
- Establish controlled, traceable and representative datasets for AI-enabled medical devices.
- Manage AI and machine learning risks throughout development and deployment.
- Improve transparency, reproducibility and trust in AI systems.
- Assess the wider impact of AI on patients, users and organizations.
- Strengthen evidence to support regulatory and compliance activities.