ISO/TR 80002-2:2017 PDF

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