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Unique Device Identification Enhancements
PTC Windchill 10.2 M010 contains several enhancements to Unique Device Identification (UDI) functionality.
Classification Trees for Quality Items
PTC Windchill 10.2 contains classification tree functionality that allows administrators to customize the items users can select when creating or editing a complaint, CAPA, or nonconformance item.
Enhancements to Customer Experience Management Reporting
PTC Windchill 10.2 contains enhanced Customer Experience Management reporting features that allow users to create and submit regulatory reports for Electronic MedWatch (eMDR), Canada, Vigilance, Australia, Japan, and Israel. Users can view and print the reports at any time.
Unique Device Identification Module for Quality
PTC Windchill 10.2 contains a new module to comply with the new Part 830 medical device regulation for the Unique Device Identification (UDI) submission process. This module allows users to create unique device identifiers for their medical devices and device packages. Users can then electronically submit the unique device identifiers to the Food and Drug Administration (FDA) Global Unique Device Identification Database (GUDID).