Medical device development.
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.
Panescu
Dorin
D
NewCardio, Inc. Santa Clara, CA, USA.
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004867:Equipment Design / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D040541:Marketing / Q000331:legislation & jurisprudence* / Q000592:standards*; D014481:United States