GfK to Discuss FDA Requirements for Medical Device Testing at Digital Health Conference

April 11, 2013

On Saturday, April 13, GfK’s Jane Lea Smith will take part in the panel “Entrepreneurship in Digital Health ­– What’s Different” at the Health 2.0 Local conference in Chicago, Illinois. Hosted by Chicago Health Tech and Health 2.0, the event is focused on fostering the growth of the health technology ecosystem in Chicago and the greater Midwest.

During this interactive panel discussion, Smith will share the basics of the Food and Drug Association’s (FDA's) guidance on medical device testing and will discuss how these requirements inform the development of mobile applications and software. The panel will present lessons learned from case studies, including considerations for the Health Insurance Portability and Accountability Act (HIPAA), Intellectual Property (IP) and state-by-state telemedicine licensing.

As a Senior User Experience Specialist, Smith has extensive experience conducting both formative and validation testing for clients in the healthcare industry, as well as designing and leading human factors studies for major medical device manufacturers submitting pre-market notifications to the FDA (510k submissions). GfK specializes in usability verification and validation for medical devices, as well as use-FMEAs that help identify risks based on simulated use.

For more information on the Health 2.0 Local Chicago conference, visit

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