Government, Technical, and Regulatory Affairs

Just as we can start to embrace and enjoy the holiday season, lurking grinch-like around the corner is the effective date of the Food and Drug Administration’s (FDA) new Quality Management System Regulations (QMSR) for medical device manufacturers – February 2nd, 2026. While much of the QMSR system will be familiar to CLMA Members – especially those already familiar with ISO 13485, there are many important questions surrounding this change. The goal of this article is for the CLMA Government, Technical, and Regulatory Committee to get some of these questions answered. Hopefully, this will help some CLMA members feel more informed and confident about the upcoming QMSR change, and they can focus on having a wonderful holiday season with their friends and families.