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Nanodevices

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Integrated Safety and Risk Assessment for Medical Devices and Combination Products

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Abstract

The incorporation of nanomaterials into medical devices has benefits and also new challenges for safety assessment. Understanding these challenges is a significant and important step in the process of practicing “safety by design” in the development of nano-enabled medical devices as well as for establishing methods and practices for safety testing. Toxicological issues are being identified and resolved for a growing number of emerging nano-enabled medical devices with product safety as the objective. This safety testing has identified challenges in test design, nomenclature, and global regulatory processes and harmonization. Nevertheless, it is clear that the incorporation of nanotechnology into medical device design most certainly is having and will continue to have major impacts toward advancing both our knowledge of the utility of nanotechnology in medicine and toward improving the quality of life of those with a variety of afflictions that need hope for a brighter future.

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  1. LoneStar PharmTox LLC, Boerne, TX, USA

    David W. Hobson PhD, DABT

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  1. David W. Hobson PhD, DABT
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Correspondence to David W. Hobson PhD, DABT .

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Hobson, D.W. (2019). Nanodevices. In: Integrated Safety and Risk Assessment for Medical Devices and Combination Products. Springer, Cham. https://doi.org/10.1007/978-3-030-35241-7_10

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