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Medical Devices and the Public's Health
Language: en
Pages: 318
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-11-25 - Publisher: National Academies Press

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In
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.
Medical Devices Law and Regulation Answer Book
Language: en
Pages: 0
Authors: Suzan Onel
Categories: Medical instruments and apparatus
Type: BOOK - Published: 2022 - Publisher:

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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Language: en
Pages: 338
Authors: Amiram Daniel
Categories: Medical
Type: BOOK - Published: 2008-01-01 - Publisher: Quality Press

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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and
An Overview of FDA Regulated Products
Language: en
Pages: 292
Authors: Eunjoo Pacifici
Categories: Medical
Type: BOOK - Published: 2018-06-13 - Publisher: Academic Press

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Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret an