Certifications

Our Quality Management System precisely defines our operational processes, their sequences, and interactions. It manages the conditions and methods required for effective operation in a predetermined manner. It continually monitors the availability of resources and information. Last but not least, it comprehensively measures, analyzes, and documents the processes.

 

ISO 13485 is a comprehensive quality management system for the design and manufacture of medical devices. The latest version of the standard, released on March 1, 2016, supersedes previous documents such as EN 46001 and EN 46002, as well as the earlier versions of ISO 13485 and ISO 13488. It provides a framework to ensure the quality and safety of medical devices throughout their lifecycle.

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