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Development of an automated sample transfer module
Project duration: 5 months
Brief description
Consulting and development support for an automated sample transfer module in line with regulatory requirements.
Supplement
The connection module for sample transfer has already completed its development on the hardware side. The software is currently under development at a third-party company. In order for a medical technology device to be certified, the development process must be documented and also the system must be verified and validated according to the required quality directives. The documents for the internal quality management handbook as well as the test strategies must be drawn up and optimized.
Subject description
In order for a project to be successful in the medical technology environment, it is necessary for clear and testable requirements to be imposed on all system levels for the HW/SW developer. The structure and levels of the requirements must be described in an overarching quality management plan. This describes the traceability between the requirements through to the test regulations.
Overview
- Industries pharmaceutical industry
- Specialist tasks BPM: process realization, ISO 13485, ISO 62304, process management, project management, quality management, sample processing, validation, work analysis
- DV tasks organisational consulting
- System environment component technology, host systems, Middleware
- Procedure model agile software development
Project period01.12.2015 - 30.04.2016
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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