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Updates in ISO 9001:2015 emphasize traceability, collaboration, and risk management throughout the product development process. In this session, attendees learned about harmonized product development and quality processes in Windchill that enable companies in highly regulated industries like medical devices to address ISO 9001:2015 updates with one PLM solution. With capabilities to manage changes throughout the product lifecycle, to trace the impact of those changes in quality feedback systems, and to address quality issues with not just corrective measures but preventive ones supported throughout the design and development process. Windchill meets the recommendations of the new standard to close the loop on product quality and product development.