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Pathology and Histopathology Evaluations of Biomaterials and Medical Devices

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Integrated Safety and Risk Assessment for Medical Devices and Combination Products

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Abstract

This chapter will focus on pathology- and histopathology-based study interactions that will optimize the study design, tissue collection and preparation, and evaluation, interpretation, and documentation of biologic responses to biomaterials and finished medical devices. Much of provided information is also applicable to pathology and histopathology evaluations of combination products (device and pharmaceutical or biologics) and regenerative medicine products that include engineered or polymer scaffolds. The reader should be familiar with and consult the most recent ISO and country-specific regulatory standards and reviews to ensure regulatory compliance with the pathology components of any study.

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  1. JCL Schuh, PLLC, Bainbridge Island, WA, USA

    JoAnn C. L. Schuh CL, DVM, PhD, DACVP

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Schuh, J.C.L. (2019). Pathology and Histopathology Evaluations of Biomaterials and Medical Devices. In: Integrated Safety and Risk Assessment for Medical Devices and Combination Products. Springer, Cham. https://doi.org/10.1007/978-3-030-35241-7_9

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