Navigating ISO 13485: A Comprehensive Guide to Medical Device Quality Management
Introduction: In the highly regulated field of medical devices, ensuring product safety, quality, and compliance is paramount. ISO 13485 stands as a globally recognized standard specifically tailored for the medical device industry. This article delves into the significance of ISO 13485, its key components, and the steps involved in achieving and maintaining certification. What is ISO 13485? ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. Published by the International Organization for Standardization (ISO), this standard provides a framework for organizations to establish and maintain processes that ensure the consistent design, development, production, installation, and delivery of medical devices that are safe and meet regulatory requirements. Key Components of ISO 13485: Quality Management System (QMS): ISO 13485 places a strong emphasis on the establishment of a robust ...