The first harmonised standard under the EU AI Act has landed, giving medical device manufacturers a much clearer route through one part of the AI Act compliance puzzle. EN 18286:2026 addresses the quality management system (QMS) requirements for providers of high-risk AI systems. For medtech companies whose products fall within the AI Act’s high-risk regime, it provides a practical framework for translating the requirements of Article 17 into an operational QMS. More importantly, manufacturers do…