Changes to the international regulatory environment

Journal of Medical Devices, Transactions of the ASME

Volumn 6, Issue 2, 2012, Pages

  McHugh, Martin ^a   McCaffery, Fergal ^a   Casey, Valentine ^a  

^a DUNDALK INSTITUTE OF TECHNOLOGY   (Ireland)

Author keywords

MDD 2007 47 EC; MDDS; Medi SPICE; Medical Device Data System; Software

Indexed keywords

DEVELOPMENT PROJECT; DIRECT IMPACT; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; INTERNATIONAL REGULATIONS; KEYPOINTS; MDD 2007/47/EC; MDDS; MEDICAL DEVICE MANUFACTURERS; MEDICAL DEVICES; MOBILE DEVICE APPLICATIONS; REGULATORY CHANGE; REGULATORY ENVIRONMENT; RULE CHANGES; SAFETY CLASSIFICATION; SPECIFIC AREAS;

COMPUTER SOFTWARE; HEALTH CARE; MANUFACTURE;

BIOMEDICAL EQUIPMENT;

ARTICLE; CARDIOVASCULAR SYSTEM; CLASSIFICATION; COMPUTER PROGRAM; COMPUTERIZED PROVIDER ORDER ENTRY; DEVICE APPROVAL; DEVICE SAFETY; ELECTRONIC MEDICAL RECORD; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; INTERNATIONAL COOPERATION; MEDICAL DEVICE; MOBILE PHONE; PATIENT INFORMATION; PATIENT MONITORING; POSTMARKETING SURVEILLANCE; RISK ASSESSMENT; UNITED STATES;

EID: 84860244255     PISSN: 19326181     EISSN: 1932619X     Source Type: Journal    
DOI: 10.1115/1.4006592     Document Type: Article

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