OVERVIEW
Implementing a UDI submission solution involves more than software configuration. Organizations must establish how device data will be sourced, maintained, validated, and approved to support ongoing regulatory submissions. They must also define governance processes, assign ownership of critical UDI attributes, and ensure that submission workflows align with both business and regulatory requirements.
Innovit’s UDI Implementation Methodology provides a structured framework for deploying Innovit’s UDI connectors and establishing the operational processes required for long-term success. Developed from real-world UDI implementation experience, the methodology guides organizations through planning, data preparation, configuration, validation, deployment, and ongoing operations. Whether implementing a new UDI program, replacing an existing solution, or expanding to support additional regulatory databases, the methodology helps organizations achieve a predictable and efficient implementation.
INNOVIT UDI IMPLEMENTATION METHODOLOGY
Innovit offers two implementation options to accommodate different organizational needs, resource availability, and levels of UDI expertise. The Self-Guided Implementation option provides organizations with self-service features, templates, product documentations, and best-practice guidance that enable internal teams to lead the project independently. This approach is ideal for organizations with simple UDI submission requirements or dedicated regulatory and IT resources that prefer to manage implementation activities themselves.
For organizations with advanced configuration requirements or seeking expert guidance, the Consulting-Led Implementation option provides direct access to Innovit’s UDI implementation experts. Innovit’s consultants work alongside your team to support planning, data readiness, configuration, validation, testing, and deployment activities.
Both implementation options follow the same proven methodology and best practices, enabling organizations to establish compliant, sustainable, and scalable UDI submission processes.
BENEFITS
Reduce Implementation Risk
Follow a proven methodology that addresses the key activities required for a successful UDI deployment, including data readiness, governance, validation, testing, and user adoption.
Accelerate Time-to-Value
Leverage established implementation frameworks, templates, and best practices to streamline project execution and achieve operational readiness more efficiently.
Establish Sustainable UDI Processes
Define clear data ownership, approval workflows, validation procedures, and governance practices that support ongoing UDI compliance beyond initial deployment.
Enhance UDI Data Quality
Implement structured approaches for data assessment, cleansing, validation, and testing to help ensure device data is accurate, complete, and ready for UDI submission.
“Innovit’s UDI Implementation Methodology combines proven best practices, regulatory expertise, and industry knowledge to help medical device manufacturers achieve successful UDI deployments.”
Implementation Options for UDI Compliance
The Innovit UDI Implementation Methodology can be delivered through either a Self-Guided or Consulting-Led implementation approach. Both options leverage the same proven framework and implementation best practices, allowing organizations to choose the level of guidance and support that best aligns with their resources, expertise, and project requirements.
Self-Guided Implementation
This option enables organizations to lead their UDI implementation using their internal resources while leveraging Innovit’s implementation methodology, best-practice guidance, templates, and product documentations. Teams can follow structured steps covering planning, data preparation, configuration, validation, and testing activities, allowing them to implement the solution at their own pace while following proven implementation practices.
Best For:
Organizations using the Freemium or Starter tiers of Innovit’s UDI solutions that have relatively simple UDI submission requirements and dedicated regulatory and IT resources with the capability and preference to manage implementation activities internally.
Consulting-Led Implementation
This option provides direct access to Innovit’s UDI implementation experts who work alongside your team throughout the project lifecycle. Innovit’s consultants provide guidance and hands-on support for requirement analysis, planning, system configuration, application integration, validation, testing, and deployment activities, helping organizations navigate more advanced implementation requirements and accelerate project execution.
Best For:
Organizations on Advanced and Professional Tiers of Innovit’s UDI products, seeking expert guidance, additional implementation support, or accelerated deployment timelines, particularly when internal UDI implementation experience or available resources are limited.
