Industry: MedTech
Client: Siemens Healthineers AG
Interoperability remains one of the major challenges in the interaction of medical devices from different manufacturers. The Siemens Healthineers Interoperability Competence Center (ICC) collects all information obtained in internal interoperability tests and during field installations and makes it available as needed. The knowledge management database used for this purpose has been validated by sepp.med.
Siemens Healthineers has set itself the ambitious goal of helping healthcare providers around the world successfully overcome their challenges. One of these challenges is integrating new devices into existing infrastructures. Interoperability plays a crucial role here. The Interoperability Competence Center (ICC) therefore conducts interoperability tests for the individual business areas. In addition, the ICC collects all information on interoperability that is obtained during the installation of devices at the customer's site.
These are collected in a knowledge database, condensed, and made available to various user groups via a proprietary application. Since this application is also used by service technicians to obtain information about settings to be made, the application had to be validated for its intended use in order to comply with ISO 13485.
Siemens Healthineers commissioned sepp.med gmbh to carry out the validation. sepp.med first conducted an inventory of the use cases to be validated. These were documented graphically as UML diagrams and further detailed in activity diagrams.
In the next step, sepp.med derived the requirements to be tested from the use cases. A risk analysis also carried out by sepp.med revealed that the application has no critical impact on product quality. The number of additional requirements resulting from the risk analysis was therefore low.
In parallel with the requirements and risk analysis, sepp.med carried out a Part 11 compliance analysis using a checklist. This did indeed reveal a number of additional requirements, some of which were implemented in the process.
A methodology that has proven particularly effective in validation was used to create the test cases: model-based testing (MBT). The basic idea behind MBT is to derive test cases that meet a specified coverage criterion from a model of the processes to be tested. Specifically, sepp.med supplemented the activity diagrams created during the requirements analysis with detailed test steps and linked all requirements to test points (see figure). Finally, the test cases were automatically generated from the diagrams using the MBTsuite test case generator.
The actual testing was performed manually and took only a few days. None of the minor deviations discovered had any impact on the usability of the database. The validation was thus successfully completed and documented in a final report.
Thanks to the graphical representation, agreement on the processes to be tested was reached very quickly. The use case diagrams visualize the planned purpose of the application and the different user groups. This clearly defines the scope of the validation.
Since the test cases were derived directly from the activity diagrams, only processes that actually occur in reality are tested. This includes error scenarios, which were also modeled.
By using the sepp.med test case generator MBTsuite, a minimal set of test cases could be generated that demonstrably covered all requirements and all decisions in the processes. A total of only 29 test cases were required to check 89 requirements.
The traceability matrix was also generated automatically, which was far less error-prone and significantly faster than manual tracking.
The validation of the knowledge management database was a relatively small validation project, but it used exactly the same approach that had proven successful for ALM tools and production processes. The use cases and processes to be tested were first graphically represented and clarified.
The test cases were created using a model-based approach and supported by tools. Automated test execution was not planned, but would also have been possible. Overall, the validation documentation created is highly traceable.
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