Regulatory Affairs


This module will provide a deep understanding on the regulatory pathways for medical devices and pharmaceuticals in Europe, the US and also have an introduction into the requirements of what is required to gain access other global markets.

Learning Outcomes

  1. Examine the regulatory pathway for medical devices and pharmaceuticals when seeking market approval in the EU and the US and other jurisdictions

  2. Evaluate how and why the regulatory environment for medical devices has changed in Europe over the last few years.

  3. Explain the various types of technical documentation required when seeking market /regulatory approval. 

  4. Determine the requirements for conducting clinical evaluation/investigations for Medical Devices.

  5. Compare and contrast post marketing surveillance requirements in US and Europe.

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