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Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study.

Fiona O'DriscollO'Brien NikiChaohui GuoMatthew PrimeAra DarziSaira Ghafur
Published in: JMIR formative research (2024)
This study proposes the simulation for regulation of SaMD framework, developed through an eDelphi consensus process, to evaluate clinical simulation when used to assess SaMD. Future research should prioritize the development of safe and effective SaMD, while implementing and refining the framework criteria to adapt to new challenges.
Keyphrases
  • healthcare
  • virtual reality
  • clinical practice