Assuring high-quality health data analysis and compliance with IEC 62304, FDA

Assuring high-quality health data analysis and compliance with IEC 62304, FDA

a1qa provided professional assistance in empowering doctors and customers with medical software and hardware complied with IEC 62304 and FDA standards.
Documentation services
Firmware testing
Functional testing
Healthcare and pharma
Mobile app testing


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.

Services offered

Functional testing
Mobile app testing
Firmware testing
Documentation services

Project scope

The client relied on the dedicated a1qa team to test a set of hardware and software products. The hardware bundle included:

  • Clinical grade sensors, which collect health data during a specified time and transfer it to the software via Bluetooth. The hardware is enhanced by advanced analytics and integrated with cloud data storage.
  • 5G smart charger, which recharges the sensors and accesses data while analyzing and sending it to the cloud.

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:

  • A mobile app for tracking health data during sleep and analyzing tiredness at work.
  • A mobile app that shows the readiness for work and overall state of health.
  • A web solution and third-party services that are integrated with the cloud storage to process collected data in a remote mode.

Holistic QA support

After delving deep into IT product’s specifics, the team embarked on testing activities.

Functional testing

During functional testing, the a1qa team helped ensure well-established interaction between sensors and apps and tested:

  • Receiving and analysis of information with the 5G smart charger (e.g., when connecting two contact elements of the sensor, the charger should indicate an error message).
  • Transmission of information to the cloud and the web application.
  • Display of corresponding user flows in the web app (five-step enrollment: sign up, verify, contract, survey, and schedule stages).
  • Synchronization of web and mobile solutions via phone number verification and unique sensor codes.

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.

Mobile app 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.

Firmware testing

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:

  1. Display of LED recharging indicators (e.g., red means low battery life, while green indicates the opposite).
  2. Correctness of pairing statuses (e.g., the blinking green – the sensor is ready to bond, the stable green – the sensor is bonded).
  3. Data collecting states (e.g., after 4 hours of ongoing data gathering, the app should show a success status, the failed status is possible in case the sensors are poorly attached or some data issues happen).

Documentation services

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.

Shaping processes

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.

Technologies & tools

  • nRF Connect
  • Android
  • Studio
  • ADB
  • DDMS
  • iTools
  • Charles Proxy
  • Fiddler
  • Postman
  • TestRail


  • With a1qa’s assistance, the client delivered IT products which complied with the industry-specific IEC 62304 and FDA standards.
  • The a1qa team helped ensure the high quality of sensor’s firmware within the robust experience of testing hardware.
  • Boosted CX within top-tier medical hardware and software flawlessly operating on mobile apps.

In numbers

year of the project duration
FTEs of functional testing involved
test cases prepared

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