Quality Assurance in Medical Software

by itsbusiness AG

Medical devices and associated software are heavily regulated.  The international standard IEC 62304– medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. In particular, you must document and verify all activities in the life cycle.


Quality Assurance is an integral part of this process. There must be involvement from QA from the start to the end of the project process. When using Agile Software development, you need to be careful to comply with verification activities.

Software must be classified according to risk (A, B C). Testing (Unit and Integration) is mandatory for Classes B and C. System testing is required for all risk classes. Unit testing is best integrated into the build process as part of a continuous integration (CI) process.

Once a stable Architecture is established, Agile Software Development can be used. There will be an overhead in verification with mini verifications required for each Sprint. Automation of regression tests (aiming to cover 70% of testing) during Sprints is important, otherwise the load for manual testing will be too great. Well trained staff and an efficient approval process are vital if you want to proceed with Agile practices, otherwise too many resources will be required during Sprints. A more detailed discussion of Agile Software Development for Medical Devices can be found here.

itsbusiness AG have a wealth of experience (over 20 years) in Test Management and testing in general, including test-automation. Our consultants have experience of all phases of projects and can help companies plan and execute Quality Management for the whole of the project life cycle. We also have a Bluetooth Testing Framework for automated testing of Bluetooth-enabled medical devices, visit our Bluetooth:

Bluetooth Testing Framework

Whitepaper | Bluetooth Testing Framework

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