Stage-gate process for the development of medical devices

Journal of Medical Devices, Transactions of the ASME

Volumn 3, Issue 2, 2009, Pages

  Pietzsch, Jan B ^a,b   Shluzas, Lauren A ^a   Paté Cornell, M Elisabeth ^a   Yock, Paul G ^a   Linehan, John H ^a,c  

^a Stanford University   (United States)

^b Wing Tech Inc   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BUSINESS PROCESS; COMBINATION PRODUCTS; CONCEPT SELECTION; COORDINATED DECISION; DESIGN AND DEVELOPMENT; DEVELOPMENT MODEL; DEVELOPMENT PROCESS; DRUG DISCOVERY; FOOD AND DRUG ADMINSTRATION; GATE PROCESS; IN-DEPTH INTERVIEWS; KEY DETERMINANTS; MEDICAL DEVICE INDUSTRY; MEDICAL DEVICES; MODEL REPRESENTATION; NEW TECHNOLOGIES; PRODUCT LAUNCH; QUALITY SYSTEMS; REGULATORY REQUIREMENTS; STANDARD OPERATING PROCEDURES; VERIFICATION AND VALIDATION;

BIOMEDICAL ENGINEERING; DRUG PRODUCTS; LAUNCHING; LAWS AND LEGISLATION; RISK ANALYSIS; RISK ASSESSMENT;

STANDARDIZATION;

DEVICE; EQUIPMENT DESIGN; HUMAN; INSTRUMENT VALIDATION; INTERVIEW; MARKETING; POSTMARKETING SURVEILLANCE; PROCESS MODEL; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; RISK ASSESSMENT;

EID: 77956313296     PISSN: 19326181     EISSN: 1932619X     Source Type: Journal    
DOI: 10.1115/1.3148836     Document Type: Review

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