Enhancement Details

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).

Product Information

Product PTC Windchill
Quality Solutions
Product / Module PTC Windchill QMS
PTC Windchill UDI
Version 10.2
Datecode F000
Product Functional Area Quality
User Interface Location 
Processes, Initiatives, and Best Practices Quality and Reliability Management

Benefits and Description

The Unique Device Identification (UDI) module in PTC Windchill 10.2 has the following benefits:

The UDI module has the following capabilities:

The UDI module delivers the following values:

UDIs can easily be brought into Windchill in two ways:

Created or imported UDIs can be independent submissions, or they can be associated with a Windchill part. Creating the UDI from a part allows the system to pre-populate information associated with the part, so users enter less information manually. Users can also create UDI templates to facilitate information entry.

For more information, see the Unique Device Identification topic in the PTC Windchill Help Center. Tip: Enter the topic name in the PTC Windchill Help Center search field to easily navigate to the topic.

Video: http://learningexchange.ptc.com/tutorial/3282/overview-of-unique-device-identification-udi

Multimedia

Images
UDI Submission Form Set Attributes Step
UDI Submission Form Set Attributes Step
UDI Submission Form Table Data Step
UDI Submission Form Table Data Step

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