Benchmarking best practices in aerospace sector for the qualification and validation of medical devices

Abstract

The validation stage in the development of a medical device plays a critical role as it demonstrates that the new product meets all the functional, reliability and quality requirements of both customer and regulatory authorities. Operating under a highly constrained process, where multiple requirements must be satisfied, the identification and implementation of innovative and improved methods can result in great cost and time savings. This project aims to develop a highly reliable and efficient procedure for the validation of medical devices. In order to achieve this, a qualitative approach has been adopted and a benchmarking study has been performed within the aerospace sector with the purpose of identifying and adapting the best practices into medical device validation procedures. The organisation current practices have been reviewed in order to identify improvement opportunities. Through several methods, including interviews, extensive literature and publications review, leading practices have been identified and proposed to the organisation. Finally, the implementation guidelines for the new procedures are provided in this research project. The outcomes of the study showed that the development of some critical procedures within the organisation, combined with an adequate resources allocation result in performance improvements and time-and-cost savings for the validation process. These results provide a starting-point for future studies basing on a quantitative approach and the particularisation of the benchmarking study scope.