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.
