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Development of a benchtop in-vitro-diagnostic medical device for POC and laboratory settings
Project duration: 11 months
Brief description
PTA supports the customer in requirements engineering for the development of an in vitro diagnostic agent for the patient-oriented laboratory diagnostics of blood gases. The focus here is on the elicitation of clients and product requirements, and the specifications are based on the product definition approach.
Supplement
The product is defined at an early stage of development through client visits and participation of all employees involved in development (business, R&D, clinical science, regulatory, quality, operations, testing and others). The requirements are determined according to the regulatory requirements of the target markets, written in EARS and recorded in a designated software (EARS = Easy Approach to Requirements Syntax).
Subject description
Over a period of more than 7 years, the customer develops a new diagnostic device. The in-vitro diagnostic device analyses blood samples at the place of care itself or in hospital laboratories. The device is primarily used for the measurement of blood gases, metabolites and electrolytes and delivers various analytical parameters in a short turnaround time with a small blood volume.
Overview
- Industries medical technology
- Specialist tasks Change Management, document management, documentation, electronic documentation, laboratory, laboratory systems, Requirements Engineering, risk analysis
- DV tasks Requirements Engineering
- Procedure model V-Modell
- Operating systems Windows 10
Project period01.06.2018 - 30.04.2019
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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