Establishing Reusable Requirements Derived from Laws and Regulations for Medical Device Development

摘要

For many industries a key activity in product development is to demonstrate legislative compliance by showing, explicitly, that all relevant requirements from regulatory documents have been identified and addressed. The analysis and interpretation of standards and regulations requires considerable skills and consumes significant effort in product development. Therefore initiating reuse from the analysis and elicitation of requirements from standards and regulations may provide promising potential for gaining efficiency in development and also for assuring sufficient quality of the work. In this paper, a method to manage requirements from standards, by establishing a reusable requirements catalogue, is suggested and a metamodel illustrating the information needed for tractability between derived requirements and legal texts, needed to facilitate reuse, is demonstrated. The paper presents a case study, where reusable requirements covering secondary packaging for medical injection devices were established, using a spreadsheet layout to capture and document the information presented in the metamodel.