An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices

In the world of modern medicine and healthcare, software plays an integral role in the functionality, monitoring, and management of medical devices. These software components can range from simple interfaces to complex algorithms that drive critical medical decisions. Ensuring the safety and effectiveness of these software components is of paramount importance, leading to the creation of standards such as IEC 62304, which defines lifecycle requirements for medical device software.

In this eBook, we cover:

  • The scope and applications of IEC 62304
  • Key concepts and terminology
  • Lifecycle process phases