Abstract
While medical devices have been derived and used since at least ancient Egypt, means of verifying their biologic safety to patients (biocompatibility) and regulations requiring and governing such pre-use evaluation (testing) are much more recent. Less than a century has seen the modern approach, with testing dictated by type, and duration, of patient contact are much more recent. Such requirements first arise in the 1960s due to concerns with materials migrated from a device into the patient body. The science and complexity of testing involved are continuously evolving (accelerated by concerns as to the safety of silicones in the late 1980’s) and have also served to drive the growth of the medical device market (now nearly a third the size of the pharmaceutical market) and the innovations and complexity of devices and device/drug combinations.
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Gad, S.C. (2019). Introduction: History and Where We Are Headed. In: Integrated Safety and Risk Assessment for Medical Devices and Combination Products. Springer, Cham. https://doi.org/10.1007/978-3-030-35241-7_1
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