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Usability validation
Project duration: 3 months
Brief description
The aim of the project is usability validation using FDA criteria.
Supplement
Technical medical diagnostic equipment has to be validated in accordance with specific standards in order to be approved for the market. This validation also includes ensuring sufficiently good usability so that no safety-critical or distorting operating errors occur. Specific guidelines have to be complied with for this usability validation, such as a set of 15 test persons and a test environment that is as similar as possible to the actual work the instrument.
Subject description
The product in question is a medical diagnosis device that is to be used in a laboratory environment. It is therefore particularly important to focus on safety-related risks during use and with the process itself, as these can have serious consequences on human life.
Overview
- Industries medical technology
- Specialist tasks design of experiments, empirical research, scientific analysis, Usability
- DV tasks Support
- System environment standard software: industry systems
- Procedure model iterative procedure
Project period01.07.2015 - 30.09.2015
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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