ISO 14155

SO 14155:2020 is an internationally recognized standard that provides practical guidance on how a sponsor should conduct a quality study on medical devices in a way that supports regulatory risk assessment. This document focuses on good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness of medical devices.

Find out more about ISO 14155 and how it can help you improve your company’s quality of output.