September 25, 2019
Monitoring in medical device studies: what is needed?
If you are a manufacturer who started a clinical trial, then you have the obligation to adequately monitor the study (MDR Article 72, par. 2; ISO 14155:2011). Monitoring is the act of overseeing the progress of a clinical investigation and to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, Good Clinical Practice, and the applicable regulatory requirements.