MEDICAL

​Wireless wearable biosensor

SERVICES:

Regulatory Advice
Ergonomics
Usability Testing
Instructional Design

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Participated in iterative design and testing of a wireless wearable sensor for use by patients in the hospital. Spent two years embedded with the development team. Assisted with the industrial design of the sensor, adhesive liners, packaging, instructions for use (IFU) and quick start guide (QSG). Conducted six rounds of usability testing, led the development of the use-related failure modes and effects analysis (UFMEA), and prepared all HF/UE documentation for FDA and CE Mark regulatory submissions.

Client

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