Technology is advancing at a remarkable pace. Can regulatory agencies keep up? They are working hard at that and in that process come many changes.

The line between what is a consumer device and what is a regulated medical device is becoming blurred. We see medical companies expanding into the consumer space and consumer companies extending into the medical arena.  Our new whitepaper provides an in-depth exploration of the potential opportunities and pitfalls, the implications for industry and how to navigate the new regulations.

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2022_The_new_FDA_Navigating_the_Moving_Line_Whitepaper.pdf
Author
David Ritscher
Connected System Architect
With a focus on connected devices, consumer products, wearables, and implantable medical  devices; design of sensor systems, algorithms, DSP, machine learning; experienced in bringing new concepts from ideation to research and development through successful product launch