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

Recognize the difference between ISO 13485 and ISO 9001. Recognize the process approach of ISO 13485. Identify management’s role in implementation and maintenance of ISO 13485 and recognize the requirements for quality management system Clauses 4-8 of ISO 13485:2016. Recognize how to ensure compliance with ISO 13485:2016.

After this course learners will be able to identify the categories of pac and the recommended chemistry, manufacturing, and control (cmc) requirements for each change.