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U.S. Department of Health and Human Services

About FDA

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Electrical and Software Engineering

The Division of Electrical and Software Engineering (DESE) participates in the Center's mission by conducting research, participating in device review activities, developing consensus standards both domestic and international, developing regulatory guidance, testing forensic and regulatory samples, and providing educational programs in the area of electrical engineering and software. Specifically, the DESE works in the application of electronics, software engineering, and systems engineering body of knowledge to the regulation of medical devices and electronic products that emit radiation. The division addresses the cutting edge of medical devices through all phases of the product life cycle and all aspects of the product manufacturer’s business, from research and development through procurement, production, and ongoing customer support. DESE hosts the following resources and capabilities: analog and digital circuit design, data acquisition and display, embedded microprocessor and PC-based systems, software-based virtual instruments, quality management and risk management as applicable to electronics and software, testing for hazards arising from the use of electrical and electronic technology in medical products, and electronic design including components, circuits, and analytical techniques for controlling high voltages and/or currents.

DESE staff members are primarily electronics engineers, physicists, biomedical engineers, and general engineers.