IEC TR 80002-2 Validation of Regulated Systems

“IEC TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems” has been published. This TR provides guidance for new requirements in ISO 13485:2016 for validating software used in quality systems. ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labeling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

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