Medical Device Software Development

Medical Device Software demands safe and reliable engineering practices.

The ANSI standard 62304-2006 abstract states: "Defines the life cycle requirements for medical device software. The set of processes, activities and tasks establishes a common framework for medical device software life cycle processes."

A summary of the sub-processes for chapter 5 is shown in the Figure below:

Medical Device Custom Software Development

DLS has experience building the software and documentation for medical devices:

  • Project development planProject development plan
  • RequirementsRequirements
  • Design documentsDesign documents
  • Unit TestingUnit Testing
  • Test plans and test reportsTest plans and test reports
  • Traceability matrixTraceability matrix