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An Introduction to ISO 13485 -- The Quality Management System for Medical Devices
This course provides an overview of ISO 13485:2003(E), which is the international quality management system standard for medical device manufacturers. The course compares ISO 13485 with its predecessor ISO 9001:2000(now revised to ISO 9001:2008) and discusses the ""process approach"" to quality management. Lastly, this course discusses the important clauses of ISO 13485 and how your organization can ensure compliance with the standard.
