AS ISO 14971:2020 PDF

This document adopts ISO 14971:2019, which specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

Edition :	1st
File Size :	1 file , 2.3 MB
ISBN(s) :	9781760729141
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	37
Product Code(s) :	10184366, 10184367, 10184368
Published :	06/26/2020