TY - JOUR
T1 - Good design practice for medical devices and equipment, Part II
T2 - Design for validation
AU - Alexander, K.
AU - Clarkson, P. J.
PY - 2000
Y1 - 2000
N2 - Medical devices and their associated process equipment must be reliable and fit for purpose. 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. A review of current literature related to good design practice carried out in Part I of this paper showed that there is inadequate guidance regarding the integration of validation with design. This paper proposes a practical approach 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 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.
AB - Medical devices and their associated process equipment must be reliable and fit for purpose. 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. A review of current literature related to good design practice carried out in Part I of this paper showed that there is inadequate guidance regarding the integration of validation with design. This paper proposes a practical approach 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 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.
UR - http://www.scopus.com/inward/record.url?scp=0033930312&partnerID=8YFLogxK
U2 - 10.1080/030919000409311
DO - 10.1080/030919000409311
M3 - Review article
C2 - 10937360
AN - SCOPUS:0033930312
SN - 0309-1902
VL - 24
SP - 53
EP - 62
JO - Journal of Medical Engineering and Technology
JF - Journal of Medical Engineering and Technology
IS - 2
ER -