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BSI PD ISO/TR 80002-2:2017

Medical device software -- Validation of software for medical device quality systems
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BSI PD ISO/TR 80002-2:2017

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

PUBLISH DATE 2017
PAGES 94
BSI PD ISO/TR 80002-2:2017

This document 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.

SDO BSI: British Standards Institution
Document Number ISO/TR 80002-2
Publication Date Oct. 31, 2017
Language en - English
Page Count 94
Revision Level
Supercedes
Committee CH/62/1
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