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Biomaterials, Medical Devices, and Combination Products - Biocompatibility Testing and Safety Assessment (Hardcover)
Loot Price: R5,396
Discovery Miles 53 960
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Biomaterials, Medical Devices, and Combination Products - Biocompatibility Testing and Safety Assessment (Hardcover)
Expected to ship within 12 - 17 working days
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Biomaterials, Medical Devices, and Combination Products is a
single-volume guide for those responsible for-or concerned
with-developing and ensuring patient safety in the use and
manufacture of medical devices. The book provides a clear
presentation of the global regulatory requirements and challenges
in evaluating the biocompatibility and clinical safety of the
materials used in producing medical devices as well as the devices
themselves. Starting with material characterization and selection,
considerations of concerns arising from packaging and contact with
production machinery, and extensive coverage of combination
products, the book also provides the latest approaches to
isolating, quantitating, identifying and assessing the risk arising
from chemical entities released from market-ready devices. Also
incorporated are new case examples and citations with the means of
access to Internet-based regulatory and scientific sites,
reflecting the universal adoption of this technology into our
world. The book takes into consideration the fact that device
markets are global, the continual advancement of technology, and
the increasing global harmonization of safety regulations. Each
aspect of device safety evaluation is reviewed in terms of the
International Organization for Standardization (ISO), US Food and
Drug Administration (FDA), European Union (EU), and Japanese
Ministry of Health, Labour, and Welfare (MHLW) perspectives.
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