Organizations are increasingly exploring how artificial intelligence can transform auditing from a periodic compliance exercise into a continuous assurance capability that provides real-time insights into quality and operational performance.
Under the QMSR, the FDA is looking not merely at whether individual procedures exist, but whether the overall quality system is capable of consistently producing safe and effective devices.
With February 2026 now behind us, the FDA’s Quality Management System Regulation (QMSR) is here. For medical device manufacturers, the question has shifted from “are we ready?” to “can we demonstrate it?”
In production AM, the question that matters is not only “Do you have a procedure?” It’s also “Can you prove what actually happened to this part, quickly, consistently, and at scale?”
Quality leaders are rethinking QMS priorities in 2026. Here are the key takeaways from the Gartner® Magic Quadrant™, and what “Ability to Execute” means for real-world quality performance.