Volume 30, Issue 3 - Medical decision making and health technology assessment
Medical Devices
Author: Namrata Upadhyay
Abstract
Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist those working in this domain, to better understand what each type of clinical investigation (CI) entails and facilitate with the medical device study designing process.
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