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ISO 13485
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prime
2 posts
May 28, 2025
10:38 PM
Medical Devices – Quality Management System
ISO 13485 medical device certification is a standard that stipulates the requirements for the quality management system of organizations providing design and development, production, installation and additional services of medical device. In addition, this standard can be applied to external organizations that provide services such as sterilization, calibration, and sales. ISO 13485
It can provide the basis for a quality management system to organizations that provide medical devices and related services.


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