Introduction to Medical Device Software Training Course

Gain an understanding of the medical device software lifecycle processes, classification rules and development activities to meet regulatory requirements.

This course is designed to provide you with knowledge of how the Medical Device Regulation (MDR (EU 2017/745)), standards and guidance documents impact medical device software; software as a medical device; and medical devices with software.

It will help you to understand how EN 62304 Medical device software - software lifecycle processes can improve your medical device software development, validation and lifecycle process.

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How will I benefit?

This course will help you to:

  • Understand the key concepts and requirements of EN 62304
  • Gain knowledge of the implementation steps of the medical device software lifecycle processes
  • Correctly classify your medical device software as per the MDR
  • Perform the necessary risk management and software lifecycle management activities