BS PD ISO/TR 80002-2:2017

Medical device software-Validation of software for medical device quality systems

BSI Group , 10/31/2017

Publisher: BS

File Format: PDF

$199.00$398.78

Description

Standard By:BSI Group , 10/31/2017

Published:10/31/2017

Pages:94

ISBN(s):9780580764257

File Size:1 file , 3.8 MB

Language:English

Note:This product is unavailable in Ukraine, Russia, Belarus

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 ED3ISO 9000:2015ISO/IEC 12207:2008 Ed 2 IEC 62304:2006/AMD1:2015IEC TR 80002-1:2009ISO 14971:2007ISO 13485:2016NIST 500-234:1996

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