March 20, 2015
The draft of the US ONC proposed 2015 HealthIT ceritfication requirements rule is at the link provided. The final will be published March 30, 2015. This new version requires use of a quality system and states: “….QMS established by the federal government and SDOs include FDA’s quality system regulation in 21 CFR part 820, ISO...
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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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