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Functional enhancement of the software for controlling and operating a diagnostic analysis device
Project duration: 1 year, 4 months
Brief description
After the audit-proof transfer of all quality-related and regulatory-related data and artifacts to a customer-specific development environment is completed, the subsequent project performs requirements management, including traceability, combined with functional enhancement of the software for controlling and operating a diagnostic analysis device.
Supplement
The technical requirements are amended, documented and managed in the HP Application Lifecycle Management tool (HP ALM), as per the customer's wishes. The project is set up in a highly regulated environment.
Subject description
The analysis device provides high-throughput diagnostic laboratories with fully automated sample preparation and -by means of real-time PCR -detection of important virological parameters for therapy monitoring. The device is operated and controlled in a standardized manner via data stations, the software for which is functionally expanded in this project.
Overview
- Industries medical technology
- Specialist tasks documentation, ISO 13485, ISO 62304, IVDD, laboratory systems, medical devices, quality management, Requirements Engineering, validation
- DV tasks Requirements Engineering
- System environment organizational consulting
- Procedure model V-Modell
- Development/ test tools HP Quality Center
Project period01.12.2013 - 31.03.2015
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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