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.
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.
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.