Introduction
The UDI Challenge IT Teams Must Solve Today
While UDI compliance is often viewed as a regulatory initiative, IT teams play a critical role in supporting implementations, enabling seamless system integrations, and ensuring enterprise applications remain secure, scalable, and reliable.
Most organizations already have product data distributed across ERP, PLM, PIM, MDM, and other enterprise systems. The challenge is enabling reliable, secure, and scalable UDI submissions without creating integration complexity, introducing duplicate master data, or increasing operational burden.
The right UDI solution should fit within the existing enterprise architecture, leverage current systems of record, automate data exchange with UDI databases, and minimize ongoing maintenance requirements.
This eBook outlines the key dimensions IT leaders, enterprise architects, and integration teams should evaluate in a UDI submission solution, and how Innovit delivers a secure, scalable, and low-maintenance solution for global UDI compliance.
Table of Contents
This eBook is structured to help you quickly navigate the key areas IT 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 evolve globally, IT teams play a critical role in enabling compliant, secure, and scalable UDI operations. While UDI compliance is often viewed as a regulatory initiative, IT teams are responsible for the underlying technology that makes compliance possible—integrating enterprise systems, securing sensitive data, supporting global scale, and maintaining reliable operations.
Innovit enables organizations to support global UDI compliance through a secure, scalable, and enterprise-ready UDI submission solution designed to simplify integrations, automate UDI submissions, and reduce long-term IT ownership.
Integrate with Existing Enterprise Systems
Innovit integrates with ERP, PLM, PIM, MDM, and other enterprise systems, enabling organizations to leverage existing product data without introducing duplicate repositories or complex integrations.
Reduce Infrastructure Management Burden
Flexible SaaS deployment options, high availability, disaster recovery, and ongoing platform maintenance help minimize infrastructure management costs and operational overhead.
Support Enterprise Security Requirements
Enterprise-grade security controls, role-based access, auditability, and compliance with industry standards help organizations protect critical product information.
Automate UDI Data Exchange
Out-of-the-box machine-to-machine connectivity eliminates custom integration development and simplifies data exchange with global UDI databases.
Scale with Business Growth
Built on the proven Genesis platform, Innovit’s UDI solution delivers the scalability needed to support growing product portfolios, expanding markets, and increasing submission volumes through cloud-native architecture and enterprise-grade performance.
Reduce Long-Term IT Burden
Continuous regulatory updates aligned with the latest UDI specifications, platform maintenance, and responsive support help organizations remain compliant while minimizing ongoing IT effort.
Data Integration & Interoperability
Data Integration & Interoperability
Can Your UDI Solution Integrate With Your Enterprise Applications Without Added Complexity?
What IT Teams Need
IT organizations already manage complex application landscapes. A UDI solution should integrate seamlessly with existing systems rather than introducing complex integrations, data flows and redundant data maintenance.
Key Concerns:
- Complex integration projects
- Duplicate product data repositories
- Custom development requirements
- Increased architectural complexity
IT teams need a UDI solution that:
- Easily integrates with existing enterprise applications
- Provides flexible integration options and file formats
- Leverages existing systems of record
- Enables transformation of source data to UDI data structures
A UDI submission solution should have the flexibility to fit into your existing IT ecosystem.
How Innovit Delivers
Innovit is designed to integrate into existing enterprise environments. This includes:
- Integration with ERP, PLM, PIM, MDM, and other source systems
- Flexible integration options and file formats
- Native data mapping & transformation capabilities
- Automated import scheduling
- Centralized staging area for data aggregation and harmonization
Product data can be leveraged from existing systems without introducing duplicate repositories or complex integrations.
1
Lower integration complexity
2
Faster implementation
3
Reduced maintenance burden
Product data is sourced from existing systems and prepared for UDI database submission without complex and costly integrations.
Why This Matters
Integration flexibility allows organizations to leverage existing enterprise investments, eliminate data duplication, and reduce the complexity of supporting UDI compliance.
Hosting, Deployment & Infrastructure Management
Hosting, Deployment & Infrastructure Management
Can the Solution Be Operated Without Adding Infrastructure Burden?
What IT Teams Need
IT teams are responsible for maintaining reliable, secure, and scalable business applications. UDI compliance should not require organizations to manage additional infrastructure, perform complex upgrades, or dedicate resources to ongoing platform administration.
Key Concerns:
- Infrastructure management overhead
- Upgrade and maintenance complexity
- Availability and disaster recovery
- Limited IT resources and operational capacity
IT teams need a UDI solution that:
- Minimizes infrastructure ownership and administration
- Supports enterprise availability and performance requirements
- Provides business continuity and disaster recovery capabilities
- Reduces ongoing operational overhead
UDI Compliance should not introduce infrastructure management burden to IT teams.
How Innovit Delivers
Innovit provides a native SaaS solution for UDI compliance designed to reduce infrastructure and operational overhead. This includes:
- Flexible SaaS hosting models
- Managed platform upgrades and maintenance
- High-availability architecture
- Disaster recovery and business continuity capabilities
- Ongoing performance, security, and platform monitoring
Organizations can support UDI compliance without dedicating internal resources to platform management.
1
Reduced maintenance costs
2
Improved reliability
3
Lower operational overhead
Innovit’s UDI solution remains available, secure, and current without creating additional infrastructure burden.
Why This Matters
Reducing infrastructure management allows IT teams to focus on strategic initiatives rather than supporting third-party technology platforms.
Security & Access Control
Security & Access Control
Can the UDI Solution Meet Enterprise Security Requirements?
What IT Teams Need
UDI platforms contain business-critical product information and must adhere to enterprise security, compliance, and governance standards. IT teams need confidence that UDI information is secure, user access is controlled, and all activities are governed through enterprise-grade security and monitoring capabilities.
Key Concerns:
- Unauthorized access to UDI data
- Security vulnerabilities and cyber threats
- Enterprise compliance and governance requirements
- Limited visibility into user activity and system usage
IT teams need a UDI solution that:
- Supports enterprise security controls
- Provides role-based access management
- Protects sensitive data
- Enables monitoring and governance of user activity
A UDI platform should ensure application and data security, not introduce new risks.
How Innovit Delivers
Innovit provides enterprise-grade security and governance controls. This includes:
- Role-based access controls
- Segregation of duties
- Secure authentication mechanisms
- Comprehensive audit trails
- Compliance with industry standards including SOC 2 & ISO 27001
Organizations maintain control and visibility while protecting critical product information.
1
Stronger security control
2
Compliance with security standards
3
Reduced operational risk
Security controls are embedded in Innovit’s UDI solution and are supported by the security, reliability, and compliance capabilities of AWS cloud infrastructure.
Why This Matters
Strong security and governance controls reduce compliance risk while supporting UDI submission and operational requirements.
Automation & Machine-to-Machine Connectivity
Automation & Machine-to-Machine Connectivity
Can UDI Data Submissions Be Automated?
What IT Teams Need
Manual submission processes increase compliance risk and often require IT teams to build and maintain custom integrations to support machine-to-machine data exchange. This approach often requires ongoing development, maintenance, and specialized knowledge of each UDI database’s technical requirements.
Key Concerns:
- Custom integration development and maintenance
- Evolving UDI database technical requirements
- Manual and error-prone UDI submissions
- Dependence on specialized UDI expertise
IT teams need a UDI solution that:
- Automates M2M submission processes out-of-the-box
- Reduces manual intervention
- Provides visibility into bi-directional data exchange
- Delivers ongoing updates as requirements evolve
Automated connectivity to UDI databases reduces complexity and improves long-term maintainability.
How Innovit Delivers
Innovit automates data exchange through built-in connectivity to UDI databases including GUDID, EUDAMED, AusUDID, swissdamed, and more. This includes:
- Out-of-the-box connectivity to UDI registries
- Automated generation of database-specific XML formats
- Built-in support for database-specific exchange protocols
- Monitoring of submission and response statuses
- Continuous updates aligned with regulatory requirements
M2M UDI submissions are streamlined and monitored without requiring custom-built solutions.
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Reduced submission errors
2
Lower integration costs
3
Faster compliance
Automated M2M connectivity enables reliable UDI data exchange without the burden of custom development or manual processes.
Why This Matters
Out-of-the-box M2M connectivity reduces implementation effort, minimizes custom development, and lowers long-term maintenance requirements.
Scalability, Performance & Global Readiness
Scalability, Performance & Global Readiness
Can the Platform Scale as Your UDI Compliance Requirements Grow?
What IT Teams Need
As organizations expand product portfolios and enter new markets, UDI systems must support increasing data volumes and evolving regulatory requirements without performance degradation.
Key Concerns:
- Growing submission volumes
- Expanding product catalogs
- Multiple regulatory jurisdictions
- Platform performance and scalability limitations
IT teams need a UDI solution that:
- Scales with business growth
- Supports global UDI requirements
- Maintains performance at volume
- Standardizes operations across regions
Your UDI platform should scale with your business, not constrain it.
How Innovit Delivers
Innovit’s UDI solution leverages the same enterprise-grade Genesis platform that powers its PIM and MDM products, supporting millions of product records and enterprise-scale product data operations. This includes:
- Support for large product records and attributes
- Reusable integration architecture
- Global UDI database coverage
- Standardized data management & submission processes
- Continuous platform optimization
Organizations can support growing product portfolios and global UDI requirements without compromising performance or scalability.
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Enterprise scalability
2
Global readiness
3
Consistent performance
Innovit’s UDI solution supports continued growth across products, markets, and regulatory requirements.
Why This Matters
Scalability ensures UDI compliance can grow alongside evolving business and regulatory requirements.
Supportability & Ongoing Maintenance
Supportability & Ongoing Maintenance
Can IT Reduce Long-Term Ownership and Maintenance Costs?
What IT Teams Need
IT teams need solutions that remain aligned with evolving UDI requirements without requiring ongoing custom development, regulatory monitoring, or significant maintenance effort.
Key Concerns:
- Evolving UDI regulatory requirements
- Ongoing platform maintenance and upgrades
- Increasing IT support demands
- Growing operational and compliance overhead
IT teams need a UDI solution that:
- Stays aligned with UDI regulations
- Simplifies regulatory complexity
- Minimizes maintenance and support effort
- Provides responsive support and ongoing updates
IT teams need a UDI solution that stays current without creating ongoing maintenance burdens.
How Innovit Delivers
Innovit reduces the ongoing burden of supporting UDI compliance by continuously managing regulatory changes, platform updates, and operational support. This includes:
- Updates aligned with evolving UDI requirements
- Platform maintenance and managed upgrades
- Performance and availability monitoring
- Security and infrastructure updates
- Responsive technical support and expert guidance
Organizations can remain aligned with evolving UDI requirements without dedicating resources to regulatory monitoring, custom development, or ongoing platform maintenance.
1
Continuous UDI compliance
2
Reduced IT burden
3
Reliable support
Innovit’s UDI solution remains current, supported, and aligned with evolving UDI requirements while minimizing long-term ownership and maintenance costs.
Why This Matters
Continuous compliance updates and responsive support reduce IT burden and help organizations stay aligned with evolving UDI requirements.
Trusted Partner with Deep Healthcare Expertise
Trusted Partner with Deep Healthcare Expertise
Do You Have a Partner That Reduces Technical and Compliance Risk?
What IT Teams Need
Successful UDI compliance requires both technical expertise and deep understanding of healthcare regulatory requirements. IT teams need a partner that combines deep healthcare and product data expertise with proven experience delivering enterprise-scale UDI compliance solutions.
Key Concerns:
- Implementation risk
- Long-term scalability
- Ongoing supportability
- Limited UDI domain expertise
IT teams need a UDI solution partner that:
- Understands healthcare technology environments
- Brings deep expertise in UDI requirements globally
- Supports enterprise-scale UDI implementations
- Provides ongoing guidance and reduces compliance risk
The right UDI solution partner helps reduce technical and compliance risk.
How Innovit Delivers
Innovit combines deep healthcare expertise with proven experience in product data management and UDI submissions globally. This includes:
- 25+ years of healthcare and life sciences experience
- Strategic partnerships with MedTech Europe, GS1, and USDM
- Support for enterprise-scale UDI compliance programs
- Active regulatory participation and early M2M testing
- Ongoing product updates, guidance, and customer support
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Reduced implementation risk
2
Trusted partnership
3
Long-term support
Organizations gain access to specialized healthcare and compliance expertise that supports successful system validation, regulatory readiness, and long-term compliance initiatives.
Why This Matters
Deep healthcare and regulatory expertise helps organizations and their IT teams navigate evolving UDI requirements with confidence.
Conclusion
Final Takeaways for IT & Enterprise Architecture Teams
UDI compliance requires a secure, scalable, and well-integrated technology foundation. Innovit helps IT teams leverage existing enterprise systems, automate UDI data exchange, and support global compliance through native integrations, enterprise-grade security, scalable architecture, and continuous regulatory alignment, thereby reducing operational complexity and long-term ownership costs.
IT Teams must be able to:
- Integrate with existing enterprise applications
- Minimize infrastructure and operational overhead
- Support enterprise security and compliance requirements
- Automate machine-to-machine data exchange
- Scale across products, markets, and regulatory requirements
- Reduce ongoing maintenance and support effort
Innovit helps organizations achieve global UDI compliance without increasing IT complexity, operational overhead, or long-term maintenance requirements.
