Medical Device QMS Overview Training
A must-take class for all medical device RA/QA professionals! This course will introduce you to the quality management system (QMS) requirements for medical devices. Designed for those who are new to the medical device field as well as experienced practitioners looking to refresh their knowledge, this course provides a solid foundation in the QMS requirements found in the US FDA Quality System Regulation (QSR) 21 CFR 820 and the ISO 13485:2016 standard. You’ll come to understand how QSR and ISO 13485 align, how they can be harmonized to maximize efficiency, and where there are opportunities to go beyond the minimum requirements to optimize performance.