A validation model for the medical devices industry

摘要

In light of the recent changes to the medical device regulations, manufacturers must now take an integrated approach to design, development and validation. Good design practice encourages this integrated approach while ensuring fitness for purpose within commercial reality. This paper proposes a practical approach aimed at making devices easier and more economic to validate. The approach comes in the form of a model of design for validation that illustrates the basic relationship between design, development and validation and a series of design tactics that were formulated in order to help designers take a more proactive approach to validation during design.