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BS PD ISO/TR 80002-2:2017

$167.64

Medical device software. Validation of software for medical device quality systems
standard by BSI Group, 10/31/2017

Category:

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
Note:
This product is unavailable in United Kingdom

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