A Guide to ISO 13485 - The Quality Management System for Medical Devices

This course serves as a guide to ISO 13485 — 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. Topics in this course include: Quality Management System, Management’s Role, Managing Resources, Planning, Design and Purchasing, Production, Monitoring and Analysis, and Improvement. This course also addresses specific aspects of ISO 13485 as it relates to the European Union (EU). After completing this course, learners will be able to recognize the specific requirements of ISO 13485 and apply them to specific situations.

Recognize the specific requirements of ISO 13485.