Global UDI Compliance via Secure Machine-to-Machine (M2M) Submission

Leverage Innovit’s UDI Connectors to automate validated UDI data exchange by connecting your internal systems directly to global UDI registries including FDA’s GUDID, EU’s EUDAMED, TGA’s ausUDID, and Swissmedic’s swissdamed.

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Purpose-Built UDI Connectors

Whether medical device manufacturers need a single UDI connector for a particular regulatory database or a UDI multi-connector to manage submissions to multiple UDI databases, Innovit provides a purpose-built, proven, and audit-ready UDI compliance solution.

Across all UDI connectors, Innovit’s solution delivers:

Centralized Data Aggregation

Consolidate device attributes from ERP, PLM, and legacy systems into a single trusted repository.

Out-of-the-Box Data Validation

Ensure “first-time-right” submissions with native business rules for each regulatory database including GUDID and EUDAMED.

Secure M2M Connectivity

Automate high-volume data exchange through secure, out-of-the-box connection using each database’s required messaging protocol & XML format.

Comprehensive Audit Trail & Submission History

Maintain a complete audit trail of data changes and a message exchange history in compliance with 21 CFR Part 11 & Annex 11 requirements.

How It Works

Best practice workflow for global UDI data management and submissions

Aggregate Device Data From Source Systems

Consolidate disparate device attributes from ERP, PLM, Excel and others into a single, centralized application for UDI data.

Maintain & Validate Data Against UDI Database Rules

Ensure submission-ready data by validating records against FDA (GUDID), EU (EUDAMED), TGA (ausUDID), Swissmedic (swissdamed), and other regulatory rules.

Automate Submission to UDI Databases

Streamline device submissions to UDI databases with secure, automated M2M submissions in their respective HL7 SPL, SOAP XML and other formats.

Monitor Status & Track Submission History

Maintain a full audit trail of UDI data changes and time-stamped submission history to support 21 CFR Part 11 and Annex 11 compliance.

Built for Every Stakeholder

Different teams, different priorities – one enterprise UDI solution that delivers value across your organization.

Regulatory Affairs (RA)

Accelerate global market access with submission-ready UDI Data

Global UDI Data Management

Global UDI Data Management – Manage GUDID, EUDAMED, ausUDID, swissdamed, and other UDI database attributes within a single, unified interface.

Native UDI Data Validation

Utilize a built-in rules engine to catch UDI data errors before they reach regulators, significantly reducing submission rejection rates.

Direct M2M Connectivity

Submit device data instantly to regulators via HL7 SPL, SOAP XML, or other native formats, eliminating manual, error-prone portal entries.

Supply Chain & Operations

Simplify UDI data management and workflow

Streamlined Data Collection

Automatically aggregate UDI attributes from ERP, PLM, and Excel to eliminate manual data entry and reduce clerical errors across the supply chain.

Flexible Approval Workflows

Configure review and approval routings that adapt to your internal SOPs, ensuring data accuracy before it reaches UDI regulators or the production floor.

Centralized UDI Data Repository

Establish a single, authoritative repository for all device identifiers and UDI attributes to drive alignment between UDI regulatory databases and physical labels.

MDM/PIM

Leverage your golden product record for UDI without rework or data duplication

Seamless UDI Data Onboarding

Ingest standardized product data directly from your MDM/PIM systems to eliminate redundant data entry and preserve your existing data investments.

Flexible Attribute Mapping

Map and transform product attributes from MDM/PIM systems to UDI fields, ensuring alignment with enterprise data models and regulatory requirements

Bi-Directional Data Synchronization

Sync relevant UDI-enriched product data back to your MDM/PIM system to continuously enhance and maintain the integrity of your product’s golden record.

Information Technology (IT)

Establish secure & scalable infrastructure for global UDI compliance

Seamless System Integration

Connect via flat-file transfers (CSV/Excel/XML), or APIs to consolidate device data from your PLM, ERP, Excel and other systems.

Enterprise-Grade Security & RBAC

Protect sensitive product data with Role-Based Access Controls (RBAC), Single Sign-On (SSO), and advanced security protocols.

Flexible Hosting Models

Choose the deployment that fits your IT strategy with options for Public Cloud, Private Cloud, or Hybrid hosting to balance scalability with control.

Quality Assurance (QA)

Ensure quality standard compliance & audit readiness

Validation-Ready Software Environment

Deploy a solution that supports GAMP 5 system validation requirements for the highest levels of system quality and reliability.

Immutable Audit Trails and eSignature

Maintain complete, time-stamped records and electronic signatures that fully satisfy 21 CFR Part 11 and EU Annex 11 requirements for data integrity.

Compliance with Quality and Security Standards

Ensure alignment with global benchmarks including GAMP (Software Quality), ISO 27001 (Information Security), and SOC 2 Type II standards.

Product Documentation

Access our high-level product, technical, hosting, and integration documentation

Product Datasheets

A high-level overview of product capabilities and data flow implementation models for UDI Multi-Connector, GUDID Connector, EUDAMED Connector and more.

Technical Datasheets

An overview of the system architecture, underlying technology stack, and system compatibility requirements needed to deploy and operate Innovit’s UDI Connectors.

Connectivity & Integrations

Guidance on integrating Innovit’s UDI Connectors into your enterprise landscape today, with current and future integration options.

Hosting Datasheet

A summary of Innovit’s cloud hosting options, underlying architecture, and included services supporting secure, reliable, and compliant operation.

Security, Quality & Regulatory Compliance

Built to meet the security, quality, and validation expectations of regulated medical device environments, including 21 CFR Part 11, Annex 11, GAMP 5, SOC 2, and ISO 27001.

Implementation Options

Innovit supports multiple implementation models, ranging from self-directed setup to dedicated implementation consulting service aligned with product tier and complexity.

Self-Guided

For Freemium and Starter Tiers

Get up and running quickly with self-guided onboarding tools designed for rapid setup, configuration, and early UDI submissions.

Dedicated Implementation Service

For Advanced and Professional Tiers

Work with Innovit experts through a guided implementation process tailored for advanced configuration requirements, integrations, and project scope.

What Our Customers Say

Reliable Data
Quality

Increased
Efficiency

Accelerated
Compliance

Customer Success Story

B. Braun Streamlines UDI Data Submission to EUDAMED with Innovit EUDAMED Connector

The Problem

B. Braun, a global medical leader, faced challenges submitting high-volume UDI data to EUDAMED. Relying on SAP ERP data, they required a robust solution to ensure data quality, manage complex attribute mapping, and eliminate risks from manual entry and inconsistent submissions across their global product portfolio.

The Solution

B. Braun implemented Innovit’s EUDAMED Connector to create an automated UDI compliance workflow. The solution onboards SAP data, validates it against EUDAMED rules, and utilizes M2M technology via AS4 for secure submissions. This GAMP 5-ready environment provides real-time monitoring, ensuring 100% transparency and accountability.

Reliable Data
Quality

Increased
Efficiency

Accelerated
Compliance

Pricing

Innovit offers flexible pricing across Freemium, Starter, Advanced, and Professional tiers—scaling from everything from initial evaluation to advanced, enterprise deployments based on requirement scope, integration needs, and usage.

Frequently Asked Questions

What is a UDI connector and how does it support UDI compliance?

A UDI connector is specialized software that streamlines the mapping, validation, and machine-to-machine transmission of device data coming from your source systems to UDI databases, so you can meet UDI device registration requirements efficiently in your markets.

What are the benefits of M2M submission over manual entry or XML bulk upload?

While manual entry is cost-effective for low volumes and XML uploads offer semi-automation, Machine-to-Machine (M2M) exchange is the only fully automated, “hands-free” solution. It eliminates error-prone manual uploads and file mapping, offering a scalable, secure, and real-time data submission path for high-volume manufacturers.

What is the difference between Innovit’s Single-Connector and Multi-Connector for UDI submissions?

A Single-Connector supports one UDI database (e.g., the FDA’s GUDID), while a Multi-Connector enables a single solution to manage attribute mappings, data validations, and submissions across multiple global UDI databases (e.g., FDA’s GUDID and EU’s EUDAMED).

Which UDI databases do Innovit’s UDI connectors support?

Innovit supports major UDI registries that offer machine-to-machine submission, including FDA GUDID (USA) and EU EUDAMED (Europe). Connectors for TGA ausUDID (Australia) and Swissmedic swissdamed (Switzerland) are planned as these authorities have plans to introduce M2M capabilities. Where M2M is not available, Innovit enables customers to manage, validate, and generate compliant XML payloads for manual submission to the applicable UDI databases.

How is device data validated before submission to UDI databases?

Innovit’s UDI connectors come pre-packaged with the specific data validation rules for their respective UDI database including the FDA GUDID and EU EUDAMED. The system enforces that you validate your records against these native business rules to ensure only validated, “first-time-right” data is approved for submission.

What data formats are supported for UDI submissions?

Innovit’s Connectors natively support the relevant XML format required by a specific UDI database, including HL7 SPL for the FDA GUDID and SOAP XML for EUDAMED.

How does Innovit’s solution support 21 CFR Part 11 and Annex 11 requirements?

Innovit maintains a permanent, time-stamped audit trail of every data change and utilizes electronic signatures for all approval workflows, ensuring your digital records meet the highest global standards for data integrity and accountability.

How does the UDI connector integrate with existing enterprise systems (ERP, PLM, RIM)?

Innovit’s UDI connectors offer flexible integration via automated file-based exchange (CSV, Excel, XML) for the simplest and most cost-effective integration needs. For more advanced environments, our Professional product tier offers a path for API-based integrations, enabling real-time data exchange with your applications.

How does Innovit keep the UDI connectors up-to-date as requirements evolve?

Innovit leverages its deep healthcare focus and active memberships in organizations like MedTech Europe to monitor UDI developments globally. Our connectors are proactively updated to the latest specifications of UDI databases—including GUDID & EUDAMED—and rolled out to you via a transparent, communicated timeline tailored to your chosen cloud hosting model.

How does Innovit support system validation requirements as per GAMP 5 standards?

Innovit provides comprehensive documentation designed to align with GAMP 5 system validation requirements for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). This simplifies your software validation process and ensures the system is “fit for purpose” in a regulated environment.

UDI Connectors