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Supervising usability activities in upgrade to new version
Project duration: 5 months
Brief description
The aim of the project is to supervise various usability activities in the upgrade to a new version of an existing product. One important factor here is documentation, which is used as verification for quality assurance by institutions such as the FDA.
Supplement
During the version upgrade, feedback on weaknesses in the field is taken into consideration and improvements are made and, in addition, new functions are added to the existing product. It is important to ensure here that the changes do not entail safety-related risks to the user or the results. This is guaranteed in various usability activities, such as a usability test and an expert review. For reasons of quality assurance, these activities are defined in a customer-specific document that also has to be presented to the FDA for approval of the equipment.
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 to the user and the process itself, as these can have serious consequences on human life.
Overview
- Industries medical technology
- Specialist tasks DIN standardization, FDA validation, QM in the project, quality assurance, Usability
- DV tasks Support
- System environment standard software: industry systems
- Procedure model customer standard
Project period02.02.2015 - 30.06.2015
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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