Clinical evaluation of cardiovascular devices: Principles, problems, and proposals for European regulatory reform

European Heart Journal

Volumn 32, Issue 13, 2011, Pages 1673-1686

  Fraser, Alan G ^a   Daubert, Jean Claude ^a   Van De Werf, Frans ^a   Estes III, N A Mark ^a   Smith Jr , Sidney C ^a   Krucoff, Mitchell W ^a   Vardas, Panos E ^a   Komajda, Michel ^a  

^a European Society of Cardiology   (France)

Author keywords

European device directives; Medical devices; Post marketing surveillance; Premarket approval; Recast of legislation

Indexed keywords

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL EVALUATION; CLINICAL PRACTICE; DISEASE SURVEILLANCE; EUROPE; HEALTH CARE PERSONNEL; MARKETING; MEDICAL EXPERT; MEDICAL PRACTICE; PRIORITY JOURNAL; PROFESSIONAL PRACTICE;

BIOMEDICAL TECHNOLOGY; CARDIOLOGY; DIAGNOSTIC IMAGING; DIFFUSION OF INNOVATION; EQUIPMENT AND SUPPLIES; EQUIPMENT DESIGN; EQUIPMENT FAILURE; EUROPEAN UNION; HEALTH CARE SECTOR; HUMANS; INTERPROFESSIONAL RELATIONS; LEGISLATION, MEDICAL; PATIENT SAFETY; UNITED STATES;

EID: 79956297293     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehr171     Document Type: Article

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