Diplomarbeiten 2010
Requirements Engineering and Management in Highly Regulated Environments – A Case Study of Developing a Requirements Concept for a Medical Device Manufacturer
Art der Abschlussarbeit
Diplomarbeit
Autoren
- Buhle, Teresa
Betreuer
- Dr. Martin Juhrisch
Abstract
Every company is confronted with its customers’ needs and expectations – their requirements.rnBeing able to identify requirements correctly, i.e., to understand the customer, and managernthem efficiently, i.e. to satisfy the customer, can be a competitive advantage for a company.rnPapers on requirements management from practitioners and scientists are various. Demandsrnfrom regulatory authorities on managing requirements are high for industries like the medicalrndevices sector. Yet, there is no panacea to the task and most companies do not manage theirrnrequirements activities systematically.rnThis paper is concerned with finding an effective requirements concept using a case studyrncompany of the medical device sector. To derive this concept an analysis of the current handlingrnof requirements in the company is conducted. From its findings the company’s deficienciesrnand possibilities for improvement regarding requirements management are identified takingrnregulatory exigencies into consideration. The main objective of this paper is to develop anrnexecutable process model based on the company’s capabilities and needs and to identify anrnadequate tool to support that process in its future execution. In order to introduce the processrnsustainably a suitable implementation strategy is also developed.
Zugeordnete Forschungsschwerpunkte
- Integration heterogener Methodenansätze
Schlagwörter
Requirements Engineering, Requirements Concept
Berichtsjahr
2010