A review of the design process for implantable orthopedic medical devices

G A Aitchison; D W L Hukins; J J Parry; D E T Shepherd; S G Trotman

doi:10.2174/1874120700903010021

A review of the design process for implantable orthopedic medical devices

Open Biomed Eng J. 2009 Jul 2:3:21-7. doi: 10.2174/1874120700903010021.

Authors

G A Aitchison¹, D W L Hukins, J J Parry, D E T Shepherd, S G Trotman

Affiliation

¹ School of Mechanical Engineering, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.

Abstract

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.

Keywords: Design; implant; medical device; orthopedic..