The FDA’s new Quality Management System Regulation (QMSR) aligns U.S. requirements with ISO 13485, shifting toward a risk-based, global approach to quality.  This reduces regulatory complexity and improves global market access for manufacturers.  FDA oversight remains, but the focus moves from inspection to proactive quality and risk management.  The result is greater efficiency, innovation, and competition.  Ultimately, QMSR advances a more harmonized, patient-centric standard for medical devices.

https://www.qualitymag.com/articles/99348-medical-device-regulation-in-the-us