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A Guide to ISO 13485 – The Quality Management System for Medical Devices (Japanese)
This course is designed to describe the basic requirements for ISO 13485:2003(E) -- the international quality management system standard for medical devices. The requirements of the standard apply to the methods used in, and the facilities and controls used for, the design and development, production, installation, and servicing of medical devices.
This course serves as a guide to ISO 13485. The requirements in the major clauses and sub-clauses of this standard are discussed.