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  3. ISO/TR 80002-2:2017 PDF

ISO/TR 80002-2:2017 PDF

ISO/TR 80002-2:2017 PDF

Name:
ISO/TR 80002-2:2017 PDF

Published Date:
06/01/2017

Status:
Active

Description:

Medical device software - Part 2: Validation of software for medical device quality systems

Publisher:
International Organization for Standardization (Technical Report)

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$83.4
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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.

Edition : 1st
File Size : 1 file , 1.8 MB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 92
Published : 06/01/2017
Same As : ISO/TR 80002-2:2017

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