Medical Devices. You better know how to test

Medical devices are one of the most interesting areas you can be involved in testing. Your testing helps you save lives. But verification and validation in MedTech have their own challenges. Automating them, even more.

SOPs are meant for human

Traditionally testing in the medical area is a manual job. This is indirectly based on the Standard Operation Procedures (SOPs). As you need to work according to these SOPs, humans can be trained on the SOPs and are automatically believed to follow the process. This is what the regulatory bodies expect in an audit.

Running verification tests manually is time intensive

Agile development is taking over in the MedTech area as well. This means faster turn-around times which leads to more rounds of verification testing. And as we all know, you cannot easily increase the speed of a manual test team by adding more resources to it.

Risk based testing is… risky

Therefore, you switch to risk based testing and old do re-testing of impacted parts. In other words, for every change in the software an impact assessment is done. Based on the impact assessment a set of test cases is identified that needs to be re-run. That is the most minimal regression testing you can think of.
Based on experiences this process is practically but leads to defects in the field. Which can eventually trigger regulated bodies and you have to answer a lot of questions. Nobody likes to send out customer letters.

A good automation can save you, a bad one will kill you

A good automation strategy allows you to implement the positive effects of agile development while simultaneously increasing your regression testing up to 90%. This saves the time invested in classical impact assessments and minimize the risk of undetected defects. For every release.

Be aware, that there are pitfalls in the typical automation tools as they were not developed for regulated environments. TestResults.io provides you full traceability, customized reports that follow your verification SOPs, simple SOUP validation, zero-level intrusion and other hard to find benefits.

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Key Facts & Benefits:

  • Complete built-in traceability
  • No risk-based testing, everything is tested
  • Full regression test on every release – no impact assessment on bug fixes or changes

Through Features

Frozen
Solutions

Validate one version of the TestResults.io engine and we make sure all your tests stick to this version. You still get the latest usability updates in the Designer or the Portal but we make sure that the tests are always executed with the specific version of the Engine that you had approved.

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Zero
Intrusion

TestResults.io uses operating system or device provided native functionalities like VNC, RDP, ADB, HDMI, … to connect to the test system. No need to install any runner means no need to modify your test environment.

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Traceability

A test case consists of test plan revisions. A test plan consists of test report revisions. Our full traceability ensures that you can easily fulfill regulations like ISO 13485.

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Visual
Testing

See and use your software as if a human would test it. No reliance on non-existing AutomationIDs or complex, always changing XPaths.

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