CE Certification for Medical Devices
<p>This course describes information about compliance of medical devices in accordance with the European Medical Device Regulations (MDR). Topics in this course include: Classification and Conformity Routes, General Requirements, Design and Construction, Technical File and Design Dossier, Quality Management System (QMS), Documentation, and Vigilance. After completing this course, learners will be able to recognize essential requirements and harmonized standards for medical devices.</p>
Recognize essential requirements and harmonized standards for medical devices. Identify significant legislative changes made to the directives. Recognize how to deal with the regulations proactively so certifications remain valid.