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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

$189.00$378.46


Published:31/10/2017

Pages:94

File Size:1 file , 3.8 MB

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 other aspect 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.

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