HQ - QMSR Central

Attention medical device manufacturers who sell your products in the U.S.: February 2026 marks a pivotal moment for your quality management system. The FDA is transitioning from the current Quality System Regulation to the new Quality Management System Regulation, which will incorporate ISO 13485:2016 standards. This change is not just an update; it’s an opportunity to enhance your processes and ensure compliance in a competitive market. Are you prepared to meet these new requirements and elevate your quality management practices to the next level?