![]() ![]() ![]() The Medical Devices and Risk Assessment section includes information on set standards as detailed by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the key steps of human health risk assessment, examples of sources for data retrieval and analysis, and calculation of a tolerable exposure limit with some implementation of uncertainty and/or safety factors as well as determination of whether a device is safe to use. For the Classification of Medical Devices section, a summary of the key classes of medical devices, as given by the FDA, is discussed. In the Overview of Device Regulation section, information is provided on the definition of a medical device as it applies to the US Food and Drug Administration (FDA). This chapter is divided into four key sections: (i) Overview of Device Regulation, (ii) Classification of Medical Devices, (iii) Medical Devices and Risk Assessment, and (iv) Case Studies. This chapter focuses on providing a brief but thorough summary of risk assessment in relation to medical devices.
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