• Armağan

Clinical Evaluation

International Medical Device Regulators Forum Final Document - 10 October 2019

This document supersedes an earlier version produced under the Global Harmonization Task Force (GHTF) with the same title in May, 2007(GHTF/SG5/N2R8:2007). What is clinical evaluation? Clinical evaluation is a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer.

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf