Course Description

Active Medical Devices in Europe: Particular Requirements

Course Description:

This course outlines the specific regulatory and normative European requirements for active medical devices in order to allow manufacturers an effective path to market.

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Learning Objectives:

Upon successful completion of this course, the learner will be able to

  • Determine the specific normative framework for active medical devices in European Union
  • Apply a step-by-step approach taking into account the specific essential requirements from applicable directives and harmonized standards
  • Apply methods for identifying the applicable standards
  • Select appropriate testing laboratories

Who Should Enroll:

Design & Development engineers, Regulatory Affairs managers, Quality Assurance managers – involved in the development and regulatory pathway with active medical devices in Europe.

Prerequisite Knowledge/Requirements:

This course requires the experience and knowledge of the subjects discussed in the following courses :

  • Project Management of Medical Device Development – ID N136
  • The European Union Regulatory System for Medical Devices – ID N145
  • The Design, Development and Industrialization of Medical Devices – ID 183
  • Importance of Technical Standards in the Medical Device Sector – ID 185
  • Risk management for medical devices in the EU and US – ID 77

Subject Matter Expert:
Martin de Bruin

58 min

Release date:

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Case studies:

Basic Account: € 177.00
Premium Account: € 133.00

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