Review of U.S. medical device regulation

Journal of Medical Devices, Transactions of the ASME

Volumn 1, Issue 4, 2007, Pages 283-292

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

^a Stanford University   (United States)

^b Wing Tech Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONTROL SYSTEMS; DRUG PRODUCTS PLANTS; INNOVATION; MACHINE DESIGN; REGULATORY COMPLIANCE;

MEDICAL DEVICE REGULATION; RISK-BASED CLASSIFICATION SYSTEM;

BIOMEDICAL EQUIPMENT;

CLASSIFICATION; COMMERCIAL PHENOMENA; DECISION MAKING; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; LAW ENFORCEMENT; MEDICAL TECHNOLOGY; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; UNITED STATES;

EID: 44849140034     PISSN: 19326181     EISSN: None     Source Type: Journal    
DOI: 10.1115/1.2812429     Document Type: Review

References (25)

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