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Verification & validation of middleware for diagnostics

Project duration: 1 year, 8 months

Brief description

The objective of this project is to verify and validate a newly developed software program in the framework of a regulated environment and the customer-specific quality management system. For this purpose, support will be provided for test strategy and the development and performance of tests, and the methods of requirements analysis and exploratory testing will be employed.

Supplement

Based the customer's V-model, the newly developed requirements are checked and proofread and test strategies are developed and documented during the analysis phase of the project. During the implementation, explorative and systematic tests are created and carried out with HP Quality Center, and fault reports are recorded in HPQC and/or ClearQuest, to keep feedback times short and enable an early correction of faults. In the final test phase, additional formal fault reports are created and assessed and IQOQ tests and regression tests are carried out. Validation is performed with Beta tests within the existing customer scenarios.

Subject description

The software product was developed on the basis of a milestone-based quality management system in order to satisfy the requirements on medical products (and IVDs) specified by the FDA or SwissMedic. By the processing of patient and diagnosis data within the product, processes such as risk management and FMEA must be taken into account, checked, and their effects documented.

Overview

Project period01.03.2011 - 15.10.2012

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