IEC 62304: medical device software - software life-cycle processes

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IEC 62304: medical device software - software life-cycle processes

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Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification — Recommend this title to your library

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Author(s): Antonio Coronato
Source: Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification,2018
Publication date January 2018

IEC 62304 is a framework of life-cycle processes, with activities and tasks, which focuses on the design and maintenance of safe medical device software.

Chapter Contents:

  • 7.1 Introduction
  • 7.2 Content
  • 7.2.1 Software Development Process
  • 7.2.2 Maintenance process
  • 7.2.3 Software risk management process
  • 7.2.4 Software configuration management process
  • 7.2.5 Software problem resolution process
  • 7.3 Use of IEC 62304 in each jurisdiction

Inspec keywords: software maintenance; medical computing; IEC standards

Other keywords: safe medical device software maintenance; safe medical device software design; software life-cycle processes; medical device software; IEC 62304

Subjects: Software engineering techniques; Biology and medical computing

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