“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...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.