概览

This on-demand training course provides the foundational principles for medical devices and combination products. Insights into the US regulations and the European Medical Device Regulation (MDR) will be shared, as well as the practical implications for manufacturers and decision-makers. The course will also provide the pharmacovigilance and surveillance requirements for devices and combination products.

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Introduction to medical devices in the US and EU
Introduction to combination products in the US and EU
Post-marketing and safety reporting in the US
Post-marketing reporting in the EU
cGMPs expectations for combination products in the US and EU

谁应该参加？

This course is designed for professionals involved in:

Global medical safety
Regulatory affairs
Clinical affairs
Quality assurance
Safety and pharmacovigilance

学习目标

At the conclusion of this module, participants should be able to:

Differentiate between medical device regulations in the US and EU
Define key terminology used in medical devices and combination products
Identify key principles in pharmacovigilance for medical devices and combination products
Recognize the use of key global safety reporting documents

注册

Essentials of Medical Devices and Combination Products

概览

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谁应该参加？

学习目标

获得信息并保持参与