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Consulting system architecture for the development of a new medical device
Brief description
The customer wants to develop a new device for screening blood reserves. The PTA advises on software and system architecture as well as regulatory issues.
Supplement
The system software is developed by the customer, and the PTA is called in as an external reviewer and consultant for decisions regarding the system architecture. The PTA also advises on questions regarding the regulatory evaluation of the medical device.
Subject description
The customer is developing a device for screening blood reserves that tests them for the most important pathogens in addition to blood grouping. The device is designed for low to medium volumes of preserves and is modular.
Overview
- Industries medical technology
- Specialist tasks Business Consulting, ISO 13485, ISO 62304, system integration
- DV tasks IT consulting
- System environment component technology
- Procedure model agile software development
Project start01.01.2019
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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