EU MDR 2017/745 Training (PART I): Introduction
Welcome to an Introduction to European Union Medical Device Regulations 2017/745. This module is an introductory module to explain how, why and when the new regulations have come into force, what they consist of and some of the new and strengthened features. We will look at some of the historical events that have occurred over a period of decades and their consequences and we will be able to see the triggers for changes in legislation and understand what brought these changes about. This module includes a high-level overview of the contents of EU MDR 2017/745, some of the new features, the timelines for compliance and we’ll take a look at how the new MDRs compare to MDD.
What Medical Device Manufacturers Can Learn from 21 CFR Part 211 Subpart D - Manufacturing Equipment Management
This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations for equipment used for medical devices/drug manufacturing and related processes.