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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


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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