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ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

This course is offered in China only and presented in Mandarin Chinese. The course materials are bilingual (English and Chinese). Currently in the industry, especially within China, product requirement development is more of an experience-based process rather than a scientific methodology. This course addresses this issue and provides a more process-driven method for better requirement development through the Quality Function Deployment (QFD) methodology.  Real industrial examples are used to demonstrate how to systematically convert the voice of the customer data to engineering specifications using QFD.