Project Leader: Grady White, NIST
Project Co-leader: Jack Zhu, Boston Scientific
Project Organizational Webinar
Statement of Work and Project Statement
The rapid growth of the use of electronics in medical devices and the recent market-driven need to shorten time to market for new products has revealed the lack of a consistent approach to determining the reliability performance of devices, such as is done in military applications through use of MIL STD. As a result, time-consuming and redundant testing occurs at many stages of the product development and qualification cycle. A standard methodology and qualification procedure would enable the industry to enact changes more quickly and to bring products to the market in a shorter time.
Scope of Work
This project will develop a reliability qualification method for portable electronic medical equipment, including the peripheral products of implantable systems. Portable medical devices are products such as patient monitoring systems that are used to measure and monitor patients’ vital signs and other bodily functions, including home diagnostics products such as blood pressure cuffs, blood glucose meters, pulse oximeters, and biochemical analysis meters. The peripheral products of the implantable medical systems, such as external chargers and remote controls, also belong to this category.
This project will:
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