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Medical Devices

An Introduction to ISO 13485 - The Quality Management System for Medical Devices

About the Course

This eLearning course provides an overview of the international quality management system standard for medical device manufacturers, ISO 13485:2016. In line with the changes to ISO 13485:2016, this course will explain how to apply a risk-based approach within a quality management system. Topics include comparing ISO 13485 with ISO 9001:2015, and how to apply a process approach to quality management. Learners will be able to identify clauses in ISO 13485:2016 and recognize ways to achieve compliance with the standard.