Day

October 12, 2012
/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdf
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An FCC mHealth task force reported recommendations to government and industry to address barriers to rapid mHealth deployment. See the link provided: FCC 2012 Mhealth Taskforce Recommendations.
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Draft of the revised MDD is at the link provided. The existing Active Implantable Device Directive is incorporated into the new MDD. EU Proposed New MDD
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Draft of the revised IVDD is at the link provided. EU Proposed New IVD
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See the attached press release from AAMI and UL regarding their collaboration to produce a series of interoperability standards. AAMI UL Interoperability Press Release
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Presentations made at the AAMI/FDA Interoperability Summit on October 1-2, 2012, can be found at the link provided. http://www.aami.org/interoperability/presentations
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Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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