The client is a US-based developer of an innovative epidermal system designed for the wireless monitoring of vital signs.
Therefore, the company was looking for professional QA assistance in empowering doctors and customers with medical software and hardware in compliance with IEC 62304 and FDA standards. The client also required professional support to release failure-proof health check sensors to the market, ensure their smooth integration with the embedded software, and increase CX.
The client relied on the dedicated a1qa team to test a set of hardware and software products. The hardware bundle included:
In order to allow end users to smoothly interact with the hardware, get the results of health state diagnostics and share them with doctors, the client developed:
After delving deep into IT product’s specifics, the team embarked on testing activities.
During functional testing, the a1qa team helped ensure well-established interaction between sensors and apps and tested:
To facilitate testing activities, the QA specialists used both real hardware and emulators.
To make the IT solutions available all around the world and prevent possible issues against non-main platforms, the a1qa team carried out cross browser and cross platform testing.
To verify that the developed apps operated as intended while sending and receiving queries under the requirements, they conducted API testing.
As some apps were designed for mobile devices, the QA engineers ensured their flawless operation against Android-based gadgets. They tested Bluetooth connection with sensors, user interface, data representation, and performed mobile app testing (including notifications, call interruptions, and co-operation with other open tabs). The team is about to expand the QA scope and carry out testing against iOS platforms.
To ensure the gathering of accurate health state information, QA engineers performed firmware testing. As the client team was constantly updating firmware, it was vital to check that the changes didn’t affect collecting and analyzing data:
To reach compliance with IEC 62304 and FDA standards, the client needed to provide the software development plan and software verification plan (used technology, performed testing types, team composition, methodology, test documentation).
To help them pass standard verification, the a1qa specialists advised on ways to compose well-organized specifications and follow the set standards regulations.
QA engineers reviewed test documentation for any inconsistencies and designed a traceability matrix to easily monitor the state of test cases. They performed a number of tests on each software requirement to guarantee maximum test coverage. Such test arrangement assisted in preparing software documentation for its standards registration and passing certification without any technical doubts.
From the very beginning of the engagement, the dedicated a1qa team smoothly adjusted to the client’s infrastructure. Once detecting a poorly established QA process, the a1qa team initiated its transformation.
QA engineers suggested moving to the TestRail test-tracking system to standardize test case creation. As for monitoring defects, they implemented Agile Board which allowed tracing created bug reports by status, assignee, and resolution.
The customer improved transparency on the project and reduced time solving issues related to controlling testing assets.
The client continues the cooperation and is planning to scale up the QA team and engross a1qa on test automation programs.