We carry out studies mainly in the field of diabetes mellitus in our institute and cooperate with external institutions. We examine and test all types of medical devices (glucose sensors, insulin pumps, blood glucose measuring devices, blood glucose test strips, lancing devices).
We focus in particular on the performance evaluation of blood glucose meters in accordance with DIN EN ISO 15197:2015, offering the following tests as a selection.
In addition, we offer manufacturers and distributors of blood glucose measuring devices the opportunity to carry out a small pre-testing of the respective test strip batch (as a quality check) before selling a test strip batch.
We offer
- Repeatability of measurements
- Evaluation of the intermediate precision of measurements
- System accuracy evaluation
- Evaluation of the packed cell volume
- Performance evaluation by the user
Our complete service
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Planing
We plan to carry out your quality assessment test.
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Testing
We test with approved and calibrated reference devices.
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Reporting
You will receive an evaluation report from us.
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Publication
Upon request, we will publish a publication evaluating your devices.
Are you interested in a performance evaluation for your medical device?
We look forward to your inquiry.
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