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The Importance of ISO 13485 in Ensuring Quality Management for Medical Devices and Its Impact on Safety
ISO 13485 is a special quality management system (QMS) made by the International Organization for Standardization (ISO). It lists detailed rules for groups that design, make, install, and fix medical devices. Unlike general standards like ISO 9001, ISO 13485 focuses more on following rules, managing risks, and keeping products safe during their whole life. In […]...
14 Oct 2025