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Language: en
Pages: 278
Pages: 278
Type: BOOK - Published: 2001-10-29 - Publisher: CRC Press
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical devic
Language: en
Pages: 490
Pages: 490
Type: BOOK - Published: 2020-02-24 - Publisher: Springer Nature
While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotox
Language: en
Pages: 526
Pages: 526
Type: BOOK - Published: 2005 - Publisher:
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Language: en
Pages: 295
Pages: 295
Type: BOOK - Published: 2022-04-07 - Publisher: Cambridge University Press
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Language: en
Pages: 141
Pages: 141
Type: BOOK - Published: 2010-10-04 - Publisher: National Academies Press
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