Full Description

BS PD ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance,manufacturing, labelling, packaging, distribution and complaint handling or to automate any otheraspect of a medical device quality system as described in ISO 13485.

This document applies to software used in the quality management system, software used in production and service provision, and software used for the monitoring and measurement of requirements.It does not apply to software used as a component, part or accessory of a medical device, or software that is itself a medical device.
Cross References:
ISO/IEC Guide 51:2014 ED3
ISO 9000:2015
ISO/IEC 12207:2008 Ed 2
IEC 62304:2006/AMD1:2015
IEC TR 80002-1:2009
ISO 14971:2007
ISO 13485:2016
NIST 500-234:1996


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 10/31/2017 ISBN(s): 9780580764257 Number of Pages: 94 File Size: 1 file , 3.8 MB Same As: ISO/TR 80002-2:2017 Product Code(s): 30251827, 30251827, 30251827