25.9.12
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Introduction to Software for Medical Devices and IEC 62304

This online course focuses on the process of developing software for medical devices. It includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software. It covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1.

Skills / Knowledge

  • Medical devices
  • Design control
  • Risk management
  • ISO 14971
  • Software development
  • IEC 62304
  • ISO 13485
  • Medical device software
  • Safety for medical devices

Issued on

February 27, 2024

Expires on

Does not expire