Medical device regulation for manufacturers

Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine

Volumn 217, Issue 6, 2003, Pages 459-467

  McAllister, P ^a   Jeswiet, J ^a  

^a QUEEN S UNIVERSITY   (Canada)

Author keywords

Health canada; Iso 13485; Iso 13488; Medical device manufacture; Medical device regulation

Indexed keywords

MANUFACTURE; PRODUCT DESIGN; PRODUCT DEVELOPMENT; QUALITY CONTROL; REGULATORY COMPLIANCE; STANDARDS; COMMERCE; HEALTH; INTERNATIONAL TRADE; SUPPLY CHAINS;

MEDICAL DEVICE MANUFACTURE; MEDICAL DEVICE REGULATION;

BIOMEDICAL EQUIPMENT;

GLOBAL HARMONIZATION TASK FORCES; ISO 13485; ISO 13488; MEDICAL DEVICE DESIGN; MEDICAL DEVICE INDUSTRY; MEDICAL DEVICE MANUFACTURERS; MEDICAL DEVICES; UNITED STATES FOOD AND DRUG ADMINISTRATIONS;

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; CANADA; COMMERCIAL PHENOMENA; EQUIPMENT; EUROPEAN UNION; HEALTH CARE QUALITY; INDUSTRY; INTERNATIONAL COOPERATION; LEGAL ASPECT; LICENSING; SAFETY; STANDARD; UNITED STATES;

CANADA; COMMERCE; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; EUROPEAN UNION; INDUSTRY; INTERNATIONAL COOPERATION; LICENSURE; QUALITY ASSURANCE, HEALTH CARE; REFERENCE STANDARDS; UNITED STATES;

EID: 1442330822     PISSN: 09544119     EISSN: None     Source Type: Journal    
DOI: 10.1243/09544110360729090     Document Type: Article

References (10)

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