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Essentials of Medical Devices and Combination Products

Discover the essential principles, regulatory insights, and compliance strategies for medical devices and combination products in this comprehensive on-demand training course.

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Overview

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.

Featured topics

  • 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

Who should attend?

This course is designed for professionals involved in:

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

Learning objectives

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

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