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

Developed a unit test framework which covered each key unit in embedded, mobile and cloud areas:
- Wireless, Medical sensors like ECG, Respiration & Temperature in embedded side
- Data retrieval/aggregator, cloud push, user interface in Android/iOS app
- Data processing/filtering, user management, plotting etc on the Linux based cloud server.
Each unit could be independently verified for input/output, code coverage etc
Corresponding documentation, code traceability, risk assessment etc needed for 62304 process were also created and submitted to FDA

Outcome and Benefits Delivered

An augmented team worked closely with development team to cover key aspects of unit testing and 62304 documentation of each unit
While the core team focused on development. A parallel team ensured verification of the unit independently. It provided a high-quality output of each unit after fully understanding the internals and requirements of each unit.
Parallel team for unit testing and documentation ensured faster submission to FDA and other testing bodies

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

PATCH units

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.

iOS-Android-App-units