Enabling Healthcare in the Home

Developing Consumer and IT Platforms in a Regulated Medical Device Environment

Article Description

Applying the development practices used in the semiconductor industry to complete regulated medical devices revealed a number of important process gaps that needed to be closed. This lead to a series of complex inside-out structural modifications to the Digital Health Group's Product Development Lifecycle, which we discuss in detail in this article. We also examine the effects of these changes on our group and the challenges we faced during the development of Intel's first FDA Class II regulated medical device. (Filetype/Size: PDF 779KB)

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