The must-take foundation course for all medical device RA/QA professionals!
Now includes an introduction to the Medical Device Single Audit Program (MDSAP) and FDA's Case for Quality.
At the end of this course, you’ll understand the basic requirements for FDA’s Quality System Regulation (QSR), ISO 13485:2016, and more. Through engaging classroom discussions, workshops, and activities, you will follow a product’s life cycle to explore how different elements of ISO 13485 and FDA’s QSR should be implemented at each life-cycle phase. You will address the major QMS subsystems and learn how to prepare for a Notified Body or FDA inspection. You’ll come to understand how QSR and ISO 13485:2016 align with one another, how they can be harmonized to maximize efficiency, and where there are opportunities to go beyond the minimum requirements to optimize performance.
Designed for those who are new to the medical device field as well as experienced practitioners looking to refresh their knowledge, this course will provide you with a solid foundation on which to build a successful career in medical device RA/QA.