As AI becomes increasingly embedded within medical devices, organizations need a structured approach to governance, compliance and accountability. This solution pack helps medical device manufacturers integrate AI governance into existing quality management systems and prepare for emerging regulatory expectations, including the EU AI Act.
Rather than creating separate management systems, this pack supports organizations in extending and enhancing their existing ISO 13485 framework with AI-specific governance and quality management requirements. The result is a more streamlined approach to managing quality, compliance and AI oversight across the organization.
What's included?
BS EN ISO/IEC 42001:2026 – Information technology. Artificial intelligence. Management system
An international standard focusing on whether an organisation governs and manages AI responsibly. Its object of assurance is the organisation and its AI management system rather than individual AI products. It covers governance areas around scope and interested parties, requires buy-in from leadership, planning, support, performance evaluation as well as continuous improvement.
BS EN 18286:2026 – Artificial intelligence. Quality management system for EU AI Act regulatory purposes
On the other hand, BS EN 18286 is designed specifically to support compliance with the EU AI Act’s requirements in Article 17 for providers of high-risk AI systems. It focuses on whether the provider’s AI quality management system ensures each AI system complies with the regulatory requirements throughout its lifecycle. Quality is defined in terms of meeting health, safety and fundamental rights and the requirements revolve around technical documentation, post-market monitoring, systems requirement engineering and verification and validation.
Who is this pack for?
Why should you use this solution pack?
As regulatory expectations for AI continue to evolve, medical device manufacturers need a practical way to govern AI technologies without creating unnecessary complexity. This solution pack helps organizations integrate AI governance into existing quality management systems, creating a more efficient route to compliance, oversight and continual improvement.
It helps you to:
This pack is particularly valuable for medical device manufacturers looking to build on their existing BS EN ISO 13485 quality management system by incorporating AI governance and EU AI Act requirements. It provides a structured and efficient approach to integrating AI management system and governance requirements into established quality processes, helping organizations avoid the complexity and duplication of managing separate quality, compliance and AI governance frameworks.