Qualification Methods for Portable Medical Products





Project Leaders

Project Leader: Grady White, NIST
Project Co-leader: Jack Zhu, Boston Scientific

End-of-Project Webinar

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:
  • Combine OEM and EMS expertise to identify current best practices in assessing reliability of portable electronic devices
  • Identify those procedures that can be applied to assessing portable medical devices
  • Identify any gaps in those procedures
  • Obtain a set of procedures acceptable to the medical electronics industry for assessing reliability of portable medical electronic products

Project Benefits

  • An industry-wide approach to qualifying the reliability performance of medical devices will enable the industry to grow faster. It will shorten the time to market and also the time to adopt and integrate new technologies into portable electronic medical devices.
  • An industry-wide approach will provide regulatory bodies with standardized criteria for acceptance of new devices or device designs.
  • An industry-wide qualification method that is supported across the supply chain will reduce redundant costly testing and increase confidence in the qualification procedure.


Grace O'Malley
+353 87 9040 363