Debrief: Medical Device Interoperability

Debrief: Medical Device Interoperability


About MDIC

Topic & Presenters

  • Introduction: Dawn Bardot, PhD, MDIC
  • FDA Draft Guidance on Interoperable Medical Devices: Bakul Patel, FDA CDRH
  • Safe Medical Device Interoperability to Enable Healthcare Transformation: Julian Goldman, MD, Massachusetts General Hospital
  • Center for Medical Interoperability Review: Ed Cantwell, Center4M


FDA Presentation

Draft guidance focuses on:

  • Design for interoperability
  • Anticipate interoperable scenarios
  • Manage and minimize risks
  • Create transparent or standards based medical device interface

FDA Slides

FDA’s position summarized in this blog

FDA Draft Guidance


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