Overview
The UDI Compliance Self-Guided Implementation approach is designed for organizations that prefer to configure and deploy Innovit’s UDI Connectors using guided setup tools, product documentation, and Knowledge Base resources.
This approach is intended for Freemium and Starter package customers implementing Innovit’s standard two-stage UDI data flow model. In this model, the solution is delivered pre-configured with the UDI data types, attributes, code lists, business rules, and submission capabilities required for the selected UDI database, enabling organizations with straightforward requirements to accelerate implementation with minimal configuration.
Although the implementation is self-guided, following these recommended activities helps establish strong data governance, improve data quality, and reduce implementation risk.
Important
Certain implementation activities cannot be completed through self-service configuration alone. Machine-to-machine (M2M) test connectivity, regulator-specific onboarding activities, and production connectivity require coordination with Innovit and, where applicable, the relevant UDI regulatory authority.
Implementation Phases
The following phases provide a recommended implementation sequence for organizations adopting Innovit’s UDI Connectors using the Self-Guided Implementation approach. Depending on the selected UDI database, implementation scope, and organizational requirements, additional activities may be required.
Getting Started
Objective
Complete onboarding activities and establish the foundation for implementation.
Customer Activities
- Finalize subscription and service agreements
- Confirm target UDI database(s) and markets in scope
- Designate business and technical implementation contacts
- Review applicable regulatory onboarding prerequisites*
- Complete required registrations and authorizations with the regulatory authority
- Schedule onboarding session(s) with Innovit
*Example regulatory onboarding prerequisites for GUDID and EUDAMED
GUDID
- Obtain a Labeler’s DUNS Number
- Submit a GUDID account request
- Specify Regulatory Contact, GUDID Coordinator, and other relevant users
- Register and authorize Innovit as a third-party submitter
- Coordinate with Innovit to establish GUDID connectivity
EUDAMED
- Obtain Single Registration Number (SRN)
- Designate a Local Actor Administrator (LAA) and other relevant roles
- Complete EUDAMED authorization requirements and upload 3rd Party Agreement
- Get Access Token (Security Key) from EUDAMED
- Coordinate with Innovit to establish EUDAMED connectivity
Innovit-Assisted Activities
- Review onboarding readiness
- Establish M2M connectivity with the target UDI database
- Configure certificates, authentication, and endpoint connectivity
- Validate connectivity prior to implementation
Deliverables
Subscription activated, customer onboarding completed, regulatory registrations initiated or completed, test M2M connectivity established, implementation environment ready
Data Readiness & Planning
Objective
Prepare source data, identify ownership, and establish the foundation for managing and submitting compliant UDI data.
Customer Activities
Data Readiness
- Identify authoritative source systems
- Identify data owners and approvers
- Review required and optional UDI attributes
- Assess data quality and completeness
- Identify data gaps requiring remediation
Submission Planning
- Confirm products and markets in scope
- Review database-specific submission requirements
- Define review and approval processes
- Assign ongoing data stewardship responsibilities
Deliverables
Products and markets confirmed, source systems identified, data ownership established, data quality assessment completed, submission governance process defined
Solution Configuration
Objective
Configure the UDI Connector to support data maintenance, validation, approval, and submission.
Customer Activities
- Configure connector settings
- Configure users and security roles
- Configure approval workflows and electronic signatures
- Configure notifications and alerts (if applicable)
Deliverables
UDI Connector configured, user access established, approval workflows operational
Data Loading & Validation
Objective
Load device data and validate readiness for submission to the relevant UDI database.
Customer Activities
Data Loading
- Import device data
- Review imported records
- Resolve import issues
Data Validation
- Perform data validation using built-in business rules
- Review warnings and validation errors
- Correct identified data issues
- Revalidate updated records
Deliverables
Device data successfully loaded, data validation issues resolved, submission-ready dataset prepared
Submission Testing
Objective
Verify configuration, data quality, and submission readiness before production deployment.
Customer Activities
- Prepare test submission datasets
- Execute submission testing
- Review acknowledgements and responses
- Resolve data validation or configuration issues
- Retest until successful
Innovit-Assisted Activities
- Support connectivity troubleshooting
- Assist with submission diagnostics where required
Deliverables
Successful test submissions, submission acknowledgements validated, production readiness confirmed
Production Readiness & Go-Live
Objective
Prepare production data and execute initial production submissions.
Customer Activities
Production Preparation
- Load production-ready data
- Perform final data validation
- Remediate outstanding errors and warnings
- Confirm production readiness
Go-Live
- Execute initial production submissions
- Review acknowledgements
- Monitor submission processing
Innovit-Assisted Activities
- Assist with production cutover
- Validate production connectivity if required
Deliverables
Production environment operational, initial submissions successfully processed and acknowledged
Ongoing Operations
Objective
Maintain ongoing UDI compliance and support continuous improvement.
Customer Activities
Operational Management
- Monitor submission activity
- Review data validation and submission exceptions
- Submit device and attribute changes within required timeframe
- Maintain alignment with ongoing regulatory updates
Continuous Improvement
- Monitor data quality dashboards
- Review submission performance
- Adopt new platform capabilities and regulatory updates
Deliverables
Accurate and compliant UDI records, ongoing submission monitoring, continuous data quality improvements, timely regulatory alignment
