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- ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
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ISO 13485 is a standard that sets out the requirements for a quality management system specific to the medical devices industry. Learn about its highlights, benefits, certification, revision, and how it relates to the FDA and other regulators.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of ...
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and...
1 day ago · ISO 13485 is the international standard for quality management in the medical device industry. Learn about its purpose, structure, requirements, benefits, and how to get certified in this comprehensive guide.
Quality management for medical devices. ISO 13485. ISO 13485, Medical devices –. Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard; written to specify requirements for an organization to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
