DocumentCode
2392573
Title
Medical device development
Author
Panescu, Dorin
Author_Institution
NewCardio, Inc., Santa Clara, CA, USA
fYear
2009
fDate
3-6 Sept. 2009
Firstpage
5591
Lastpage
5594
Abstract
The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.
Keywords
biomedical equipment; marketing; product design; product development; business expertise; marketing; medical device development; medical product design; product development; product verification; regulatory approval; Medical device; development; market release; regulatory approvals; validation; verification; Device Approval; Equipment Design; Equipment and Supplies; Marketing; United States;
fLanguage
English
Publisher
ieee
Conference_Titel
Engineering in Medicine and Biology Society, 2009. EMBC 2009. Annual International Conference of the IEEE
Conference_Location
Minneapolis, MN
ISSN
1557-170X
Print_ISBN
978-1-4244-3296-7
Electronic_ISBN
1557-170X
Type
conf
DOI
10.1109/IEMBS.2009.5333490
Filename
5333490
Link To Document