Medical device development: from prototype to regulatory approval.
Kaplan
Aaron V
AV
Section of Cardiology, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756-0001, USA. aaron.v.kaplan@hitchcock.org
Baim
Donald S
DS
Smith
John J
JJ
Feigal
David A
DA
Simons
Michael
M
Jefferys
David
D
Fogarty
Thomas J
TJ
Kuntz
Richard E
RE
Leon
Martin B
MB
D000046:Academic Medical Centers / Q000191:economics / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods; D018795:Device Approval / Q000331:legislation & jurisprudence; D004867:Equipment Design / Q000191:economics / Q000379:methods; D004864:Equipment and Supplies / Q000145:classification; D005062:European Union; D006801:Humans; D018973:Intellectual Property; D015337:Multicenter Studies as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D012109:Research Support as Topic; D014481:United States; D014486:United States Food and Drug Administration