The Role of FDA in Health Care Software Regulations and Development

September 24, 2015 - Fremont CA US

Compliance4all

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Overview: This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device

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