ISO 13485

ISO 13485 is a sector-specific quality standard for the medical device industry. The standard’s full name is 
ISO 13485, Medical Devices – Quality Management Systems — Requirements for Regulatory Purposes.

Medical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products

 

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