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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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