skip to Main Content


Medical Software Testing According to ISO 13485 – 5 Things to Consider

What are the most important things to consider in planning and implementing effective and standard-compliant testing of medical software?

Medical Software Testing

From the point of view of patient safety it is crucial that medical devices work correctly – the worst possible consequence of an error could be lost human life. Testing plays an important role in ensuring the quality of the medical device.

In practice, quality should be taken into account throughout the whole life cycle of the product. The ISO 13485 standard defines a quality management system that can be used in organizations that need to manage the life cycle of a medical device.

Five things to consider in testing of medical software

In software testing, the test coverage is not the only factor to consider. The earlier bugs are detected in the software, the cheaper it is to fix them. For this reason, testing should be done as early as possible in the software development process.

In our white paper, we tell you more about medical software testing according to ISO 13485. We highlight five things that should be taken into account when planning and implementing effective and standard-compliant testing of medical software.

What, for example, should the test plan contain? Or what does traceability mean and why is it important? Download our white paper and learn more about medical software testing!

Download now

Want to learn more about our expertise? Contact us!