MV-TMM: Une approche multi vues pour la gestion de la traçabilité des exigences

The approach MV-TMM (Multi View Traceability Management Method) presented in this thesis aims to guide the companies in their design of requirements traceability models adapted to the context of their projects. This is achieved by allowing the construction of a model based on trace fragments adapted to each phase of the development process or to a specific situation. Furthermore, the approach guides the users to use the traceability model in a requirement management tool. They help them capture and mange the evolution of the traceability data.Après une étude de l‘état de l‘art dans le domaine de la traçabilité des exigences, nous avons constaté que la gestion de la traçabilité a fait l‘objet de plusieurs travaux de recherche. Malgré ces travaux, nous avons constaté que les entreprises rencontrent encore des difficultés à intégrer la traçabilité dans leurs processus de développement. Cela est dû au manque de mécanisme de représentation des différents types d‘informations de traçabilité ainsi qu‘à la méconnaissance du processus de traçabilité des exigences dans un projet.Le travail de cette thèse propose une solution dénommée MV-TMM (un démarche multi vues pour la gestion de la traçabilité) composée de deux éléments principaux : (i) un méta modèle multi vues permettant la représentation des différents types d‘informations de traçabilité et (ii) un processus intentionnel décrivant les étapes nécessaires pour la construction et l‘usage des informations de traçabilité

Impact of EU Medical Device Directive on Medical Device Software

Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls