After completing this module, you will be able to:

Narrate benefits of ISO 13485:2016.
Trace the development of ISO 13485:2016.
Explain practical steps to company certification on ISO 13485.
Examine types of available personal certifications.
Realize standard terminologies and definitions related to stakeholders, product, QMS, Risk and Sterilization.
State available standards on Medical Devices' Quality Management System. 
Describe ISO 14971 and why it is important for QMS.
Differentiate ISO 13485:2003 and ISO 13485:2016.
Compare FDA 21 CFR Part 820 with ISO 13485:2016.
Learn the summary of ISO 13485:2016 covering all auditable clauses.
List the mandatory documents defined in ISO 13485:2016.