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Open Biomed Eng J. 2009 Jul 02;3:21-7. doi: 10.2174/1874120700903010021.

A review of the design process for implantable orthopedic medical devices.

The open biomedical engineering journal

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

Affiliations

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

PMID: 19662153 PMCID: PMC2713416 DOI: 10.2174/1874120700903010021

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.

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