REVIEW ARTICLE
A Review of the Design Process for Implantable Orthopedic Medical Devices
G.A Aitchison1, 2, D.W.L Hukins1, J.J Parry2, D.E.T Shepherd*, 1, S.G Trotman2
Article Information
Identifiers and Pagination:
Year: 2009Volume: 3
First Page: 21
Last Page: 27
Publisher ID: TOBEJ-3-21
DOI: 10.2174/1874120700903010021
Article History:
Received Date: 09/3/2009Revision Received Date: 19/5/2009
Acceptance Date: 24/5/2009
Electronic publication date: 02/7/2009
Collection year: 2009
open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.
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.