PTC UNIQUE DEVICE
IDENTIFICATION SOLUTION
PTC Unique Device Identification Solution
Compliance without Complexity
The PTC Unique Device Identification (UDI) solution, developed with the FDA and major medical device manufacturers,
provides for the end-to-end submission needs of the FDA UDI ruling. Whether you’re only seeking a solution to manage
submissions or a comprehensive offering that encompasses both data management and submissions, the PTC UDI solution
provides preconfigured, out-of-the-box technology and training that enable your company to quickly gain compliance with
both FDA and future, worldwide UDI regulations.
Key Benefits
• Improve efficiency by centrally gathering UDI data
• Speed the review and approval process by routing UDI data to the right organizational roles
• Quickly and accurately manage large amounts of similar data via templates and bulk-load capabilities
• Help reduce rejected submissions by using the same data checks as the FDA
• Synchronize UDI data as product changes are made upstream to ensure submissions are kept current
• Keep a change-controlled history of UDI submissions and agency responses for audit trail and future regulatory needs
• Cross-reference UDI requirements from other geographies to manage future global compliance needs
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Comprehensive Capabilities
The PTC UDI solution offers the fastest and lowest-risk way to meet the end-to-end submission requirements of the FDA
UDI regulation. Suitable for any sized company – whether they make ten products or ten thousand products – the PTC UDI
solution reduces the risk of noncompliance with pre-configured software, training, and services.
Proven UDI Compliance Software
• Developed in conjunction with the FDA and major medical
device manufacturers
PTC UNIQUE DEVICE IDENTIFICATION SOLUTION
Communicates and tracks UDI requirements
• Supports FDA and worldwide geographies
• Offers pre-submission data validation using FDA's
own algorithms
Get Compliant Quickly
• Streamline and accelerate the UDI data gathering,
transformation, and submission processes
• Help ensure accuracy by facilitating complete compliance
• Uphold all of the related industry standards required
under FDA UDI
Governs the UDI submission process
Reduce the Risk of Audits
• Track FDA responses and immediately flag exceptions for
quick correction
• Enable an enterprise view of compliance across all
product lines
• Automatically update UDI submissions as product
data changes
Meet Complex Compliance Needs
• Manage many similar products efficiently
Manages changes to keep UDI submissions current
• Quickly create submissions for every product version,
variant, and configuration
• Anticipate the submission needs of future UDI
regulations globally
Services Expertise
• Fast, 3-4 month deployment timeframe
• Includes comprehensive, 21 CFR Part 11-compliant
training delivered by industry experts
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PRODUCTS
DB 3
DATABASES
DB 1
DB 4
APPROVED
PRE-SUBMISSION
VALIDATION
DB 2
PTC UDI Solution
STREAMLINE RESPONSE
MONITORING AND
ERROR HANDLING
GLOBAL REGULATIONS
AUTOMATED WORKFLOW FOR
EDIT, REVIEW & APPROVAL
The PTC UDI Solution is available either as a submission-only or as a complete UDI data management and submission
package. The complete PTC UDI solution helps centralize and manage UDI data for companies who house product data in
multiple systems across the enterprise.
Implementing Unique Device Identification with PTC Global Services
On Site Deployment: Industry experts in PTC Global Services have developed a rapid approach to deploy the PTC UDI
solution and have your team up and running within 90 days or less, including 21 CFR Part 11 compliance training
delivered by eLearning and Instructor-led options.
The Global Services Value-Ready Deployment approach emphasizes two critical success factors:
• Strategic Alignment: Rapid, cross-functional alignment on implementation objectives, timelines, governance,
and metrics
• Process-Led Approach: Best practice processes built into PTC software to simplify deployment, accelerate UDI
compliance, and maximize flexibility for future organizational needs
PTC Managed Services: If desired, PTC can deploy, host, and provide ongoing application management in a secure
PTC datacenter to further minimize in-house IT requirements, and ensure optimal solution performance.
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TO LEARN MORE about the PTC’s Unique Device Identification solution please visit:
PTC.com/solutions/udi-solution/
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© 2014, PTC Inc. All rights reserved. Information described herein is furnished for informational use only, is subject to change without notice, and should not be
taken as a guarantee, commitment, condition or offer by PTC. PTC, the PTC logo, Product & Service Advantage, Creo, Elements/Direct, Windchill, Mathcad,
Arbortext, PTC Integrity, Servigistics, ThingWorx, ProductCloud and all other PTC product names and logos are trademarks or registered trademarks of PTC
and/or its subsidiaries in the United States and other countries. All other product or company names are property of their respective owners.
J3038–UDI-BRO–EN–0114