Essentials of Medical Devices and Combination Products

Keyword(s) Regulatory Affairs; combination products; drug safety; pharmacovigilance; risk management; medical devices

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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Credit Information 6.5 ACPE
0.7 IACET

Tag(s) On Demand Training, Regulatory Affairs, Regulatory, Safety & Pharmacovigilance, Medical Devices & Diagnostics

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Description

FEATURED TOPICS

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