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This document provides a discussion of the context for important factors and questions that manufacturers should consider when designing, testing, installing, and maintaining connected medical devices.

The scope of this TIR includes:
  • Considerations for adding interoperability or connectivity to the function of a device
  • Modifying existing functionality of a connected device
  • Considerations when developing connections between devices from multiple vendors
  • Questions manufacturers should ask themselves when adding/modifying interoperable functionality