Title :
Medical device development
Author_Institution :
NewCardio, Inc., Santa Clara, CA, USA
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;
Conference_Titel :
Engineering in Medicine and Biology Society, 2009. EMBC 2009. Annual International Conference of the IEEE
Conference_Location :
Minneapolis, MN
Print_ISBN :
978-1-4244-3296-7
Electronic_ISBN :
1557-170X
DOI :
10.1109/IEMBS.2009.5333490
