Introduction
The UDI Challenge PIM & MDM Teams Must Solve Today
PIM and MDM teams are the custodians of trusted product data across the enterprise. As UDI regulations continue to expand globally, organizations increasingly rely on their PIM and MDM platforms as the authoritative source for core device information.
However, UDI compliance requires more than maintaining and governing core product master data. Product data must be mapped and transformed into the data model required by each UDI database, validated against the latest business rules, and submitted using the appropriate format and data exchange protocol.
The right UDI submission solution should complement existing PIM and MDM investments, not duplicate them. It should efficiently source product data from PIM and MDM systems, simplify mapping and transformation into UDI-specific data dictionaries, provide out-of-the-box data validations aligned with database requirements, and automate submissions to global UDI registries without introducing redundant maintenance or governance processes.
This eBook outlines the key capabilities PIM and MDM professionals should evaluate in a UDI submission solution, and how Innovit enables scalable global UDI compliance while maximizing existing PIM and MDM investments.
Table of Contents
This eBook is structured to help you quickly navigate the key areas PIM & MDM professionals should evaluate in a UDI submission solution. Each section focuses on a specific requirement, outlining what to look for, how Innovit delivers and why it matters.
Use the table of contents to jump directly to the sections most relevant to your priorities or current challenges.
Executive Summary
System Integration & Data Aggregation
System Integration & Data Aggregation
Data Management and Approval Workflows
Ease of Use
Audit Trail & Traceability
Submission Control & Visibility
M2M Data Submission
Compliance Standards and System Validation
Implementation Speed & Cost Efficiency
Support and Ongoing Maintenance
Reliable Partner with Deep Healthcare Expertise
Conclusion
Executive Summary
As UDI requirements continue to expand globally, PIM and MDM teams play a critical role in ensuring trusted product data can support regulatory compliance. While organizations may consider extending their PIM or MDM platforms with UDI-specific data models, business rules, governance processes, and M2M integrations, building and maintaining these capabilities can become costly and difficult as regulations evolve and new UDI databases emerge.
Innovit helps organizations leverage existing PIM and MDM investments by sourcing trusted product data directly from systems of record, transforming and validating it against UDI database rules, and automating submissions to global UDI registries. This enables PIM and MDM teams to focus on managing core enterprise product data while Innovit manages the requirements of global UDI submissions.
Leverage Existing Product Data
Innovit sources device data directly from PIM, MDM, ERP, PLM, and other enterprise systems, eliminating duplicate data repositories and avoiding the need to build UDI-specific data models within existing master data platforms.
Extend Governance & Stewardship
UDI governance should complement existing enterprise data governance practices. Innovit extends ownership, approvals, and data quality controls to UDI processes without creating disconnected governance models.
Improve UDI Data Quality
Innovit provides native UDI database data models, business rules, stewardship workflows, and monitoring capabilities that help ensure device data remains complete, accurate, and compliant with evolving UDI requirements.
Gain Complete Data Lineage
Innovit’s Visual Rules Framework (VRF) provides transparency into source-to-UDI data mappings and transformations, while audit trails, approval history, and submission tracking ensure complete traceability from source data through regulatory submission.
Eliminate Custom UDI Connectivity
Out-of-the-box connectivity to global UDI registries eliminates the need to build and maintain custom integrations while providing visibility into submission status, acknowledgements, and regulatory outcomes.
Scale Global UDI Compliance
Innovit continuously maintains UDI data models, validation rules, and connectivity while supporting expanding product portfolios, global regulatory requirements, and large-scale compliance operations in a single platform.
Accelerate Time to Compliance
Innovit enables rapid implementation through pre-configured data models, workflows, and flexible deployment options, reducing complexity and allowing organizations to achieve UDI compliance efficiently.
Leverage Proven UDI Expertise
Backed by deep expertise in healthcare, product master data management, and global UDI compliance, Innovit helps organizations reduce implementation risk, accelerate compliance, and navigate evolving regulatory requirements with confidence.
Integration with PIM, MDM and Other Systems
Integration with PIM, MDM and Other Systems
Can You Leverage Existing Product Data Without Turning Your PIM or MDM Into a UDI Compliance Platform?
What PIM & MDM Teams Need
PIM and MDM systems already serve as the authoritative source for product information across the enterprise. While organizations may consider building UDI-specific data models, validation rules, and submission capabilities directly within their PIM or MDM platform, doing so often requires significant implementation effort and ongoing maintenance as global UDI requirements evolve.
PIM and MDM teams need a UDI solution that leverages existing product data investments while avoiding the complexity of building and maintaining UDI-specific capabilities from the ground up.
Key Concerns:
- Duplicate product data maintenance
- Multiple sources of truth for UDI data
- Building and maintaining UDI data models
- Ongoing support for evolving UDI requirements
PIM & MDM teams need a system that:
- Integrates easily with existing product data sources
- Leverages systems of record
- Simplifies transformation into UDI data models
- Eliminates the need to build and maintain UDI-specific capabilities
PIM and MDM systems should manage core product data. UDI solutions should leverage that data and transform it into compliant UDI submissions.
How Innovit Delivers
Innovit enables organizations to leverage existing enterprise product data while avoiding the effort of building and maintaining UDI-specific capabilities within their PIM or MDM environment. This includes:
- Integration with PIM, MDM, ERP, PLM and other source systems
- Pre-configured UDI data dictionaries and business rules
- Native mapping and transformation capabilities to UDI data model
- Out-of-the-box connectivity to global UDI databases
Core product data remains governed within existing systems of record while Innovit’s UDI solution manages the UDI-specific requirements needed for successful submissions to global UDI registries.
1
Single source of truth
2
Reduced implementation effort
3
Lower maintenance burden
UDI-specific data models, data validation rules, and submission capabilities are provided out-of-the-box rather than custom built and maintained within the PIM or MDM platform.
Why This Matters
Leveraging existing product data while avoiding custom development reduces cost, accelerates compliance, and allows PIM and MDM teams to remain focused on core product master data management activities.
Data Governance & Stewardship
Data Governance & Stewardship
Can You Extend or Optimize Existing Governance Processes to Support UDI Compliance?
What PIM & MDM Teams Need
PIM and MDM teams establish governance frameworks to ensure product data is managed consistently, securely, and accurately across the enterprise. While UDI compliance introduces additional regulatory requirements, governance processes for UDI data should complement existing master data governance practices rather than create disconnected ownership models, workflows, and controls.
The goal is not to replicate enterprise governance processes for UDI data, but to extend and optimize them to support regulatory compliance while maintaining consistency, accountability, and data quality.
Key Concerns:
- Disconnected governance processes
- Unclear ownership of UDI data
- Manual review and approval activities
- Inconsistent data quality controls
PIM & MDM teams need a system that:
- Complements existing governance frameworks
- Supports role-based ownership and security
- Enables controlled review and approval workflows
- Extends data quality and auditability controls to UDI data
UDI governance should complement enterprise data governance, not operate separately from it.
How Innovit Delivers
Innovit extends enterprise data governance practices into UDI compliance while supporting the unique requirements of UDI data management, validation and submission. This includes:
- Role-based access controls
- Defined ownership of UDI attributes
- Configurable review and approval workflows enabled with eSignature
- Built-in audit trails and version history
- Native data validation and quality controls
UDI-specific governance processes support regulatory compliance while complementing broader enterprise data governance practices.
1
Consistent data
governance
2
Improved
data quality
3
Clear
accountability
UDI data is managed through controlled access, workflows, and approvals that bring transparency and accountability to the UDI submission process.
Why This Matters
Extending governance practices to UDI data improves accountability, strengthens data quality, and reduces redundant or disconnected governance processes.
UDI Data Quality & Validation
UDI Data Quality & Validation
Can You Ensure UDI Data Quality Without Building Custom Business Rules and Stewardship Capabilities?
What PIM & MDM Teams Need
PIM and MDM platforms provide the foundation for managing high-quality product data. However, UDI compliance introduces additional data requirements, data validation rules, and stewardship processes that are specific to UDI databases and continually evolve over time.
While organizations can build UDI-specific data models, business rules, validations, and monitoring capabilities directly within their PIM or MDM platform, doing so often requires significant implementation effort and ongoing maintenance.
PIM and MDM teams need a UDI solution that leverages existing product data while providing UDI-specific data validation rules, quality controls, and stewardship capabilities out-of-the-box.
Key Concerns:
- Building and maintaining custom UDI data validation rules
- Managing evolving regulatory requirements
- Limited visibility into UDI data quality issues over time
- Manual identification and remediation of data gaps
PIM & MDM teams need a system that:
- Provides native data validation rules for global UDI databases
- Ensures validated UDI data prior to submission
- Supports stewardship and remediation workflows
- Stays up to date with the latest regulatory requirements
PIM and MDM systems manage enterprise product data quality. UDI submission solutions should ensure that product data meets the requirements of each UDI database.
How Innovit Delivers
Innovit provides native data validation, stewardship, and monitoring capabilities for global UDI registries including GUDID, EUDAMED, AusUDID, and swissdamed. This includes:
- Out-of-the-box data validation rules
- Automatic validation check prior to submission
- Data quality dashboard for each UDI database
- Efficient issue identification and remediation
- Automated feedback of data validation reports to source systems
1
Trusted UDI
data quality
2
Reduced data
validation effort
3
Faster issue resolution
UDI data quality issues are identified and managed through purpose-built controls rather than custom-developed PIM or MDM rules that are difficult to maintain.
Why This Matters
Purpose-built UDI data quality controls help ensure device data remains complete, accurate, and compliant with evolving requirements across global UDI databases.
Auditability & Data Lineage
Auditability & Data Lineage
Can You Trace Product Data from Source System to Submission?
What PIM & MDM Teams Need
PIM and MDM teams are responsible for maintaining trusted product data and providing transparency into how that data is used across the enterprise. When product data is transformed for regulatory purposes, organizations need visibility into how source attributes were mapped, transformed, validated, and ultimately submitted to UDI databases.
Teams also need visibility into who changed UDI data, what changes were made, when they occurred, and how those changes impacted the final regulatory submission.
Key Concerns:
- Limited transparency into UDI data mappings and transformations
- Difficulty tracing data lineage from source to submission
- Lack of visibility into data changes, approvals, and submissions
- Difficult root cause analysis for data quality issues
PIM & MDM teams need a system that:
- Provides transparency into UDI data mappings and transformations
- Maintains traceability from source data through submission
- Tracks changes, approvals, and submission activity
- Enables data quality monitoring and stewardship
Trusted UDI data requires complete visibility from source to submission.
How Innovit Delivers
Innovit provides complete visibility into how product data is transformed, maintained, approved, and submitted throughout the UDI submission process. This includes:
- Visual Rules Framework (VRF) for visual attribute mapping and transformation
- End-to-end lineage from source records to UDI submissions
- Data quality monitoring and stewardship dashboard
- Audit trails for data changes, approvals, and submission activity
- Submission status, acknowledgement, and history tracking
1
Complete traceability
2
Improved accountability
3
Faster issue resolution
Attribute mappings, transformations, approvals, and submissions remain fully visible and traceable to ensure reliable UDI submissions.
Why This Matters
Complete visibility into UDI data lineage, governance activities, and submission history simplifies audits, improves stewardship, and accelerates the resolution of data quality issues.
Native M2M UDI Submission
Native M2M UDI Submission
Can You Support Global UDI Submissions Without Building Custom Connectivity?
What PIM & MDM Teams Need
Organizations often consider building custom integrations to individual UDI registries from their PIM or MDM systems. While custom integrations to UDI databases may appear straightforward initially, they often become increasingly difficult to maintain as regulatory requirements evolve and new registries emerge. Organizations must continuously manage submission protocols, technical connectivity, and regulatory changes while retaining specialized knowledge across multiple UDI databases.
As UDI regulations continue to expand globally, organizations need a scalable approach that enables trusted device data to flow into UDI registries without continuously developing and maintaining registry-specific integrations.
Key Concerns:
- Custom integration development and maintenance
- Ongoing regulatory and technical changes
- Scaling compliance across global UDI databases
- Loss of institutional knowledge and expertise over time
PIM & MDM teams need a system that:
- Simplifies connectivity to global UDI databases
- Supports expansion to new regions without custom development
- Provides transparency into submission processes and outcomes
- Reduces dependency on specialized UDI expertise
UDI connectivity should not become a permanent maintenance project for PIM, MDM and IT teams.
How Innovit Delivers
Innovit provides pre-built connectivity to global UDI databases including GUDID, EUDAMED, AusUDID and swissdamed, eliminating the need for organizations to build and maintain custom integrations. This includes:
- Out-of-the-box M2M connectivity to global UDI registries
- Registry-specific data exchange protocols and XML formats
- Complete submission and response tracking
- Data quality and submission dashboard for each UDI registry
- Submission status reporting back to source systems
UDI data is validated and submitted through out-of-the-box M2M connectivity that evolves alongside changing regulatory requirements.
1
Reduced implementation effort
2
Lower maintenance burden
3
Faster time
to compliance
UDI submissions are managed through pre-built connectivity rather than custom-developed integrations and submission processes.
Why This Matters
Out-of-the-box UDI database connectivity reduces implementation cost, minimizes ongoing maintenance, and helps organizations scale UDI compliance globally.
Ongoing Regulatory Alignment, Scalability & Support
Ongoing Regulatory Alignment, Scalability & Support
Can Your UDI Compliance Strategy Scale as Requirements Continue to Evolve?
What PIM & MDM Teams Need
UDI compliance is not a one-time implementation for global device manufacturers. Regulatory requirements continue to evolve, new UDI databases are introduced globally, and product portfolios expand over time. Organizations need a solution that can support ongoing UDI regulatory alignment while scaling efficiently across growing product catalogs, markets, and compliance obligations.
PIM and MDM teams should not be responsible for continuously updating UDI data models, data validation rules, and submission requirements as regulations evolve.
Key Concerns:
- Maintaining UDI data models and validation rules as requirements evolve
- Supporting new UDI registries and regulatory requirements globally
- Scaling governance processes across growing product portfolios and markets
- Increasing operational effort to support UDI compliance
PIM & MDM teams need a system that:
- Maintains alignment with evolving UDI requirements
- Supports global UDI expansion
- Scales with growing product portfolios
- Enables repeatable and efficient UDI compliance processes
UDI compliance should scale seamlessly with your product portfolio and market footprint, not increase your maintenance burden.
How Innovit Delivers
Innovit provides a purpose-built UDI solution that continuously evolves alongside global regulatory requirements while supporting scalable compliance operations. This includes:
- Timely software updates aligned with evolving UDI requirements
- Out-of-the-box support for new UDI databases and regulatory regions
- Continuous maintenance of UDI data models, business rules, and M2M connectivity
- Scalable governance, review, approval, and submission workflows
- Enterprise-grade platform scalability for large product portfolios and submission volumes
Organizations can support growing product portfolios, expanding market requirements, and evolving regulations without continuously extending PIM and MDM platforms.
1
Continuous regulatory alignment
2
Global UDI compliance scalability
3
Reduced
maintenance effort
UDI compliance processes remain current, scalable, and repeatable as regulatory requirements, product portfolios, and market coverage continue to expand.
Why This Matters
Organizations can support evolving global UDI requirements without increasing the maintenance burden on PIM and MDM teams.
Trusted Partner with Deep Healthcare Expertise
Trusted Partner with Deep Healthcare Expertise
Do You Have a Partner That Understands Both Product Master Data and UDI Compliance?
What PIM & MDM Teams Need
Managing and governing enterprise product data requires specialized expertise, tools and processes. UDI compliance introduces an additional layer of complexity, including UDI-specific data models, validation requirements, submission protocols, and evolving global regulations.
While organizations can develop this expertise internally, doing so often requires significant investment and creates ongoing dependency on specialized resources and institutional knowledge.
PIM and MDM teams need a partner that understands both enterprise product data management and the unique requirements of global UDI compliance.
Key Concerns:
- Limited UDI domain expertise
- Evolving global regulatory requirements
- Dependence on specialized internal resources
- Long-term scalability and support
PIM & MDM teams need a solution partner that:
- Understands healthcare product data
- Brings deep UDI regulatory expertise
- Supports enterprise-scale compliance initiatives
- Provides ongoing guidance and timely solutions as requirements evolve
Keeping pace with global UDI requirements requires expertise as much as technology.
How Innovit Delivers
Innovit combines deep healthcare domain knowledge with extensive experience in product data management and global UDI compliance. This includes:
- 25+ years of healthcare and life sciences experience
- Proven expertise in UDI, GDSN, PIM and MDM
- Strategic partnerships with GS1, MedTech Europe, and USDM
- Active participation in global UDI initiatives and M2M testing
- A proven track record of successful global UDI deployments
Organizations gain access to specialized UDI expertise without building and maintaining it internally.
1
Reduced implementation
risk
2
Trusted expertise
3
Long-term partnership
Organizations can achieve and maintain UDI compliance with greater confidence and less complexity.
Why This Matters
Specialized expertise helps organizations navigate evolving UDI requirements while reducing reliance on internal regulatory and technical resources.
Conclusion
Final Takeaways for PIM & MDM Professionals
PIM and MDM systems remain the foundation of trusted product data. However, UDI compliance requires additional capabilities to transform, validate, and publish that data according to the requirements of global regulatory databases. Innovit extends existing PIM and MDM investments by simplifying data sourcing, transformation, validation, and submission, enabling organizations to achieve scalable global UDI compliance without introducing duplicate systems or governance processes.
PIM & MDM Teams must be able to:
- Leverage existing PIM and MDM investments
- Simplify data mapping and transformation to UDI data models
- Validate natively against the latest UDI specifications
- Automate regulatory submission and response tracking
- Scale globally through a single platform
Innovit extends existing PIM and MDM investments that organizations have made with UDI-specific capabilities required for global compliance.
