Medical Device Manufacturers
Unify UDI compliance, GDSN syndication, PIM, and MDM into a single governed product data foundation.
Accelerate global commercialization, simplify regulatory compliance, and streamline your end-to-end supply chain.
Unify UDI compliance, GDSN syndication, PIM, and MDM into a single governed product data foundation. Accelerate global commercialization, simplify regulatory compliance, and streamline your end-to-end supply chain.
Establish Trusted Product Master Data Across the Healthcare Value Chain
Innovit provides a proven product data foundation for medical device manufacturers operating in a complex, multi-regulator environment. By harmonizing UDI, GDSN, PIM, and MDM into a single governed platform, we eliminate the risks of data fragmentation and ensure trusted product data powers your regulatory submissions, commercial operations, and global healthcare supply chains.
Streamline Global UDI Compliance
Automate submissions to UDI databases including GUDID, EUDAMED, AusUDID and swissdamed through a single, validated global UDI solution.
Accelerate Omnichannel Growth
Launch products faster with verified, channel-ready product data tailored to your trading partners.
Optimize Supply Chain Operations
Drive efficiency in your logistics, shipping, and other supply chain processes.
Improve Cross-Functional Alignment
Align regulatory, quality, supply chain, and commercial teams around a single and authoritative product data.
Key Challenges Facing Device Manufacturers
Growing UDI Compliance Burden Across Global Markets
Medical device manufacturers face evolving UDI regulations and complex regional compliance requirements. Fragmented product data makes it difficult to maintain audit-ready UDI submissions to GUDID, EUDAMED, ausUDID, swissdamed, and more, while managing change control and data consistency across multiple jurisdictions.
Trading Partner & Global Commerce Requirements
Distributors, GPOs, and healthcare providers demand specific product data standards and synchronization methods. Without verified, publish-ready product information, medical device manufacturers struggle to meet either standardized or unique trading partner requirements while supporting omnichannel commercialization.
Operational & Supply Chain Demands
Inconsistent product data creates friction across planning, fulfillment, and logistics. Manual workarounds and mismatched product attributes result in inefficient supply chain execution, inaccurate inventory forecasting, and significantly higher operational costs.
The Solution: A Unified Foundation for
Global Product Data Requirements
Innovit delivers a GAMP 5 validation-ready platform that unifies UDI, GDSN, PIM, and MDM capabilities to create a centralized solution that harmonizes the technical, regulatory, clinical, and commercial product data needed for the healthcare value chain.
Global UDI Submission
Ensure accurate, audit-ready UDI submissions from a single platform across global UDI databases including FDA GUDID (US), EUDAMED (EU), ausUDID (AU), swissdamed (CH), and more.
Global GDSN Publication
Publish standardized and verified product data to distributors, GPOs, and providers through GDSN-certified data pools like 1WorldSync, atrify, NPC, and TrueSource for seamless product synchronization.
Product Information Management (PIM)
Go beyond supply chain data with a healthcare-focused PIM that centralizes rich content, product catalogs, multilingual attributes, and digital assets—enabling channel-ready product content.
Master Data Management (MDM)
Establish a governed “single source of truth” for master data across ERP, PLM, labeling, regulatory and commercial systems improving data consistency, change control, reporting accuracy & supply chain execution.
Built for Every Stakeholder
Different teams, different priorities — one platform for trusted product data
Regulatory Affairs (RA)
Maintain audit-ready device records and accelerate global UDI regulatory submissions
Global UDI Submission Readiness
Prepare and validate device data for timely, error-free submission to the GUDID (US), EUDAMED (EU), ausUDID (AU), swissdamed (CH), and other global UDI databases.
Audit Trail & Traceability
Enforce strict approval workflows with eSignatures, versioning, and time-stamped audit trails to ensure 100% transparency and audit-readiness.
Global Regulatory Agility
Adapt instantly to evolving UDI mandates worldwide, allowing you to scale market expansion without compromising compliance.
Supply Chain & Operations
Reduce supply chain disruptions with consistent, trusted product master data
Standardized Item Master
Establish a “Single Source of Truth” for weights, dimensions, packaging, and Units of Measure (UOM) to streamline logistics and warehouse management.
Verified Data Synchronization
Ensure seamless distribution of validated supply chain data to both global regulators and commercial trading partners simultaneously.
End-to-End Traceability
Access a complete lineage of product data to accelerate recall management and ensure precise UDI tracking across the global value chain.
E-Commerce/Digital Marketing
Deliver consistent, optimized product experiences across every digital channel
Rich Content & Digital Asset Management (DAM)
Centralize the management of rich product content, including images, videos, 360° views, and IFUs, to provide a consistent, high-quality brand experience for all partners.
Global Market Localization
Manage multilingual attributes and regional marketing descriptions in a single hub to accelerate the rollout of international product launches.
Channel-Ready Publishing
Automate the delivery of optimized product content tailored to the specific requirements of e-commerce platforms, trading partner portals and digital catalogs.
Product Content Syndication
Master the complexity of diverse trading partner requirements with ease
Certified GDSN Integration
Utilize native connectivity to GDSN data pools like 1WorldSync, atrify, GHX, NPC, and TrueSource for automated product data synchronization.
Customer-Specific Mapping
Tailor product data to satisfy the unique, non-standardized requirements of specific distributors, retailers, and hospital networks.
Syndication Health Monitoring
Track publication status and data quality scores in real-time to ensure your product information is live and accurate across channels.
MDM/PIM
Establish a governed “Golden Record” for enterprise product master data
Single Source of Truth
Automatically aggregate, de-duplicate and cleanse attributes from ERP, PLM, Excel and legacy silos into a single, authoritative “Golden Record”.
Data Quality & Governance Workflows
Implement role-based data stewardship workflows to ensure data completeness, accuracy, and compliance before it reaches downstream systems.
Automated Data Syndication
Streamline the distribution of governed, “Golden Record” product data to all internal and external systems to harmonize global operations.
Information Technology (IT)
Establish secure & scalable infrastructure for global UDI compliance
Seamless System Integration
Leverage flexible options, including automated file transfers (CSV/XML/Excel) and APIs, for bi-directional connectivity to enterprise applications.
Enterprise Grade Security & RBAC
Protect sensitive IP with Role-Based Access Controls (RBAC), Single Sign-On (SSO), and advanced security protocols.
Flexible Hosting Models
Align with your global IT strategy by selecting the optimal deployment model from Public Cloud, Private Cloud, or Hybrid to balance enterprise-wide scalability with localized data 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.
Why Device Manufacturers Choose Innovit
Industry expertise, proven solution, and strategic focus on bringing quality to healthcare master data
25+ Years of Healthcare Specialization
Strategic memberships & partnerships with key industry players including MedTech Europe, GS1 Healthcare, HTG, and USDM Life Sciences.
Proven & Scalable Enterprise Solution
Battle-tested, enterprise-grade software used by the world’s leading medical device manufacturers.
Rapid Deployment & Time-to-Value
Structured implementation methodology, an easy-to-use interface, and an embedded knowledge center, with on-hand expert support.
Uncompromising Security & Quality Standards
Compliant with the most rigorous requirements, including GAMP 5 system validation, ISO 27001, SOC 2, 21 CFR Part 11, and EU Annex 11.
Trusted By
Industry Leaders
We’re proud to work alongside industry-leading healthcare brands that trust us to drive innovation and success.
Partners in Healthcare
MedTech Europe
MedTech Europe is the European trade association representing Diagnostics & Medical Devices Manufacturers operating in Europe.
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USDM Life Sciences
USDM Life Sciences is a consulting firm focused on GxP compliance, validation, cloud compliance, quality systems, and regulated technology services in healthcare.
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GS1 Healthcare
GS1 Healthcare leads stakeholders in developing and implementing global supply chain standards to improve efficiency across the healthcare sector.
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Healthcare Transformation Group
HTG collaborates with GS1 Healthcare, government, vendors, and research partners to promote and accelerate the adoption of global healthcare standards.
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What Our Customers Say
Scaling Seamlessly Towards UDI and GDSN Compliance
“We expanded to the UK and Netherlands market at fraction of cost when compared to our initial efforts in America and Canada, resulting in a net savings of more than 85% per market.
Innovit helped us overcome so many challenges by allowing us to implement a global system and unified process that’s fully integrated with our internal systems.”
Ready to Elevate Your
Global Product Data?
Join leading medical device manufacturers using Innovit to meet global product data requirements, from UDI compliance to supply chain optimization and scalable commercial growth.
Ready to Elevate Your Global Product Data?
Simplify global UDI data submissions, ensuring quality & security, and accelerating market access.