Quality management staff who are new to medical devices, regulatory staff seeking a refresher in quality system requirements, and management staff not directly in charge of compliance issues but wanting an overview are all encouraged to take this course. In addition, any staff member who has taken the ISO 13485:2003 course should take this updated version with all the new requirements that were included in the ISO 13485:2016 standard published March 1, 2016.
The following material is required:
Familiarity with other quality system standards or regulations, such as ISO 9001
A copy of the ISO 13485:2016 standard
