Updated CE Marking Process & ISO 13485:2016 Expectations

Overview: It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016. Learning Objective: Upon completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implement.