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Medical Device Safety
Language: en
Pages: 278
Authors: G.R Higson
Categories: Medical
Type: BOOK - Published: 2001-10-29 - Publisher: CRC Press

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Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical devic
Integrated Safety and Risk Assessment for Medical Devices and Combination Products
Language: en
Pages: 490
Authors: Shayne C. Gad
Categories: Medical
Type: BOOK - Published: 2020-02-24 - Publisher: Springer Nature

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While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotox
Advances in Patient Safety
Language: en
Pages: 526
Authors: Kerm Henriksen
Categories: Medical
Type: BOOK - Published: 2005 - Publisher:

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v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Innovation and Protection
Language: en
Pages: 295
Authors: I. Glenn Cohen
Categories: Law
Type: BOOK - Published: 2022-04-07 - Publisher: Cambridge University Press

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A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Public Health Effectiveness of the FDA 510(k) Clearance Process
Language: en
Pages: 141
Authors: Institute of Medicine
Categories: Medical
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