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Paperback Integrated Safety and Risk Assessment for Medical Devices and Combination Products Book

ISBN: 3030352439

ISBN13: 9783030352431

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

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Format: Paperback

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Book Overview

While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation.

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