Risk Assessments for Medical Devices

  • Erica N. RogersEmail author


This chapter focuses on providing a brief but thorough summary of risk assessment in relation to medical devices. 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. 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). For the Classification of Medical Devices section, a summary of the key classes of medical devices, as given by the FDA, is discussed. 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. Lastly, this chapter provides two fictious case studies which assist readers in understanding how to apply the steps of human health risk assessment to determine an appropriate TE limit.


Medical device Risk assessment Tolerable exposure (TE) Uncertainty factor (UF) 


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© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Gad Consulting ServicesRaleighUSA

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