A review of the design process for implantable orthopedic medical devices.
The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.
Aitchison
G A
GA
School of Mechanical Engineering, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Hukins
D W L
DW
Parry
J J
JJ
Shepherd
D E T
DE
Trotman
S G
SG