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International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products
Language: en
Pages: 616
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Type: BOOK - Published: 2019-08-30 - Publisher: CRC Press

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Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace accep
International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products
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Type: BOOK - Published: 1995-05-01 - Publisher: Interpharm Press

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Medical Device Regulations
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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health
Medical Regulatory Affairs
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This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, an
Public Health Effectiveness of the FDA 510(k) Clearance Process
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Pages: 141
Authors: Institute of Medicine
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Type: BOOK - Published: 2010-10-04 - Publisher: National Academies Press

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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse