ISO 13485

ISO 13485:2003 Quality Management System for Medical Devices

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices published by International Organization for Standardization in 2003. The standard provides a framework for a comprehensive management system for the design and manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

It is especially relevant to manufacturers who wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers

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