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Introduces the topics covered by the book and the introductory concepts. It clarifies what is medical device software, what is not, and emphasizes the differences between the new categories of medical device software and the classic medical devices. It also introduces regulations, standards, and practices. The need for medical software compliance is explained. The aim of this book is to explore this complex scenario and to illustrate how to exploit techniques, methodologies, development processes, and existing standards to realize high-quality medical purpose software, according to the regulations. The certification of SaMD is the goal of the engineering tasks illustrated in the book.

Chapter Contents:

  • 1.1 The evolution of medical purpose software
  • 1.2 Product quality and software quality
  • 1.3 On the need for quality in medical purpose software
  • 1.4 Regulatory environments
  • 1.5 Verification and validation
  • 1.6 Structure of the book

Inspec keywords: standards; software quality; medical computing

Other keywords: SaMD certification; regulations; medical device software; high-quality medical purpose software; standards

Subjects: Software engineering techniques; Biology and medical computing

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