Author:
Aitchison G.A,Hukins D.W.L,Parry J.J,Shepherd D.E.T,Trotman S.G
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.
Publisher
Bentham Science Publishers Ltd.
Subject
Biomedical Engineering,Medicine (miscellaneous),Bioengineering
Reference46 articles.
1. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Official J Eur Commun
1993;
L169
: 1-43.
2. McAllister P, Jeswiet J.
“Medical device regulation for manufacturers,”
Proc Inst Mech Eng Part H J Eng Med
2003;
217
: 459-67.
3. BS EN ISO 13485: 2003 Medical devices - Quality management systems-Requirements for regulatory purposes.
London: British Standards Institute 2003.
4. PD CEN ISO/TR 14969: 2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003.
London: British Standards Institute 2005.
5. FDA 21CFR820 Quality System Regulation.
Rockville, Maryland, USA: Food and Drug Administration 2006.
Cited by
37 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献