title: Medical device development: from prototype to regulatory approval.
authors.affiliation: Section of Cardiology, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756-0001, USA. aaron.v.kaplan@hitchcock.org
authors.forename: Aaron V
authors.initials: AV
authors.lastname: Kaplan
authors.forename: Donald S
authors.initials: DS
authors.lastname: Baim
authors.forename: John J
authors.initials: JJ
authors.lastname: Smith
authors.forename: David A
authors.initials: DA
authors.lastname: Feigal
authors.forename: Michael
authors.initials: M
authors.lastname: Simons
authors.forename: David
authors.initials: D
authors.lastname: Jefferys
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Fogarty
authors.forename: Richard E
authors.initials: RE
authors.lastname: Kuntz
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: 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