Success Stories

Unit Testing and 62304 documentation for IoMT

One healthcare provider was working on a new product that could do
Remote patient monitoring, using a device to collect vitals like ECG, Respiration & Temperature. This data was periodically retrieved by the iOS/Android app and uploaded to the cloud for monitoring and Analysis. They needed support in expediting FDA and 62304 processes, especially in Unit testing of all components.

Solution Description

Outcome and Benefits Delivered

System Description

The Wireless ECG system consists of 3 Components Patch(Medical device), Mobile app, Cloud server

Patch

Patch is a coin cell operated wearable device which collects 4 lead ECG and Respiration and temperature from human body. Patch digitize data and transmits it over WiFi. Unit test and documentation were done for each of the below units

System Description

Mobile phone - receiver

Receiver unit collects the data from a patch in periodic manner without wasting power in patch. Also maintains user related information and cloud upload.


Cloud Server

Linux based server aggregates all data from different patches and displays it in near realtime for healthcare staff to monitor


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