ISO 13485 Medical Devices Quality Management System

The ISO 13485: 2003 standard was created on the basis of the ISO 9001: 2000 standard, it is an international standard that contains special requirements for medical devices.

In addition to fulfilling legal requirements, medical device manufacturers who want to gain competitive advantage must prove that they comply with the requirements of the quality management system.

ISO 13485 Medical Devices Quality Management System

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