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Change Expectations > Change Technology > Change Healthcare The Medical Device "Plug-and-Play" (MD PnP) Interoperability Program is promoting innovation in patient safety and clinical care by leading the adoption of secure patient-centric integration of medical devices and IT systems in clinical environments. |
Resources
| QUICK LINKS > MD PnP White Paper > ICE Standard (ASTM F2761) > MD FIRE RFI & RFP ............................................ BECOME A MEMBER > Benefits of Membership > Membership Application ............................................ CONTACT INFORMATION MD PnP Program 65 Landsdowne St., Suite 200 Cambridge, MA 02139 info@mdpnp.org Julian M. Goldman, MD Program Director jgoldman@mdpnp.org Drayton Freeman Program Assistant dwfreeman@mgh.harvard.edu |
External Resources on Medical Device Interoperability
AAMI white paper on Medical Device Interoperability, published March 2012
July 2011 IOM report on 510(k) regulatory framework, "Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years"
July 2011 IOM report on 510(k) regulatory framework, "Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years"
White paper of the California Healthcare Institute, "Upcoming Changes to the 510(k) Process: New Approval Pathways and the Impact on Medical Device Development and Innovation"
The Open Group's Semantic Interoperability Work Group
WHO publication, Medical Device Regulations: Global Overview and Guiding Principles
Device Advice: Comprehensive Regulatory Assistance from the FDA
mHealth Regulatory Coalition's Proposed Guidance on Regulation of mHealth Technologies, submitted to the FDA in September 2011
Friends of the MD PnP Program