Good design practice for medical devices and equipment, Part II: design for validation

Medical devices ant their associated process equipment must be reliable and fit for purpose. In light of the recent changes to the medical device regu lations, manufacturers must now take an integrated approach to design, deve lopment and validation. Good design practice encourages this integrated app roach while ensuring fitness for purpose within commercial reality. A revie w of current literature related to good design practice carried out in Part I of this paper showed that there is inadequate guidance regarding the int egration of validation with design. This paper proposes a practical approac h to design for validation aimed at making devices easier and more economic to validate. The approach comes in the form of a model of design for valid ation that illustrates the basic relationship between design, development a nd validation and a series of design tactics that were formulated in order to help designers take a more proactive approach to validation during desig n.