Innovit
Innovit provides cloud-based solutions for EUDAMED and UDI compliance, helping medical device suppliers and healthcare providers manage and validate regulatory data for global compliance and patient safety.
Innovit specializes in simplifying the complex process of managing, validating, and exchanging trusted product data to ensure regulatory compliance. Their solutions are designed to help medical device suppliers and healthcare providers meet stringent global UDI requirements, including EUDAMED and AusUDID mandates. With a focus on product information management and global data syndication, Innovit offers user-friendly, certified GDSN solutions and cloud-based platforms like EUDAMED.cloud. These tools enable organizations to gain visibility into data requirements, train staff, and submit validated data to regulatory agencies efficiently. They also assist in improving product data quality, driving supply chain analytics, and enhancing patient safety. Innovit's expertise extends to navigating the evolving landscape of country-specific UDI regulations, offering a central hub for resources and solutions to achieve worldwide UDI compliance. They empower businesses to take full control of their compliance processes, meet ever-changing deadlines, and address the commercial needs of healthcare providers.
About
**Who they are**
Innovit is a global solution provider specializing in Master Data Management (MDM), Product Information Management (PIM), Global Data Synchronization Network (GDSN), UDI Compliance, and NPI Workflow Automation software. They offer cloud-based solutions designed to assist medical device suppliers and healthcare providers with regulatory data management.
**Expertise & scope**
* Provides cloud-based solutions for EUDAMED and UDI compliance.
* Helps manage and validate regulatory data for global compliance and patient safety.
* Offers tools to prepare for EUDAMED compliance, including data requirement visibility, staff training in a playground environment, and go-live submission capabilities.
* Supports UDI compliance across various global regulations, including those in the United States (FDA/GUDID) and the European Union (MDR/EUDAMED).
* Develops solutions for managing and exchanging accurate regulatory data critical in healthcare and life sciences.
**Reputation / proof points**
* Operates globally with listed offices in the United States, Australia, and the United Kingdom.
* Supports healthcare providers, medical device suppliers, and GPOs & Distributors.
Innovit is a global solution provider specializing in Master Data Management (MDM), Product Information Management (PIM), Global Data Synchronization Network (GDSN), UDI Compliance, and NPI Workflow Automation software. They offer cloud-based solutions designed to assist medical device suppliers and healthcare providers with regulatory data management.
**Expertise & scope**
* Provides cloud-based solutions for EUDAMED and UDI compliance.
* Helps manage and validate regulatory data for global compliance and patient safety.
* Offers tools to prepare for EUDAMED compliance, including data requirement visibility, staff training in a playground environment, and go-live submission capabilities.
* Supports UDI compliance across various global regulations, including those in the United States (FDA/GUDID) and the European Union (MDR/EUDAMED).
* Develops solutions for managing and exchanging accurate regulatory data critical in healthcare and life sciences.
**Reputation / proof points**
* Operates globally with listed offices in the United States, Australia, and the United Kingdom.
* Supports healthcare providers, medical device suppliers, and GPOs & Distributors.
Additional information
Innovit's EUDAMED.cloud solution is designed to facilitate compliance with upcoming mandatory EUDAMED usage, starting May 28, 2026. The platform offers features such as templated data import/export (Excel/CSV), pre-configured review and approval workflows, and XML export for bulk uploads to EUDAMED. They provide different pricing tiers based on the number of UDI records and named users supported, with options for up to 200 UDI records and 4 named users. Buyers can also explore their UDI Knowledge & Expertise resources and playground environments for training and testing.
Key Highlights
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Offers cloud-based solutions for EUDAMED and UDI compliance.
Source
“Innovit provides cloud-based solutions for EUDAMED and UDI compliance, helping medical device suppliers and healthcare providers manage and validate regulatory data for global compliance and patient safety.”
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Provides tools for EUDAMED data management, validation, and submission.
Source
“We have all the tools you need to prepare for EUDAMED compliance”
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Supports global UDI compliance, including US FDA/GUDID and EU MDR/EUDAMED.
Source
“In the United States, the Food & Drug Administration (FDA) has set the UDI standards and established a database called the Global Unique Device Identification Database (GUDID).”
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Has a global presence with offices in the United States, Australia, and the United Kingdom.
Source
“1900 South Norfolk St,Level 3, Suite 350San Mateo, CA 94403United States of America”
Certifications & Trust Signals
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Founded as a global solution provider specializing in MDM, PIM, GDSN, UDI Compliance, and NPI Workflow Automation.
Source
“Innovit is a global solution provider specializing in MDM (Master Data Management), PIM (Product Information Management), GDSN (Global Data Synchronization), UDI Compliance (Unique Device Identification) and NPI Workflow Automation software.”
Buyer Snapshot
Best for
- Medical device suppliers needing EUDAMED and UDI compliance solutions.
- Healthcare providers managing regulatory data.
How engagement typically works
- Cloud-based software solutions.
- Direct sales and support engagement.
Typical deliverables
- EUDAMED compliance tools.
- UDI data management and submission support.
- MDM and PIM solutions.
Good to know
- Best when organizations require structured data management for global regulatory compliance.
Pricing
Model:
Usage-based
Public range:
Publicly listed: €150 – €400 per month for EUDAMED.cloud
Notes:
Based on publicly listed information for EUDAMED.cloud; final fees depend on scope and specific plan selected.
“Pricing: €150 per month; €250 per month; €400 per month”
HQ:
Austin, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
ES, NL, SE, PL, DE, DK, IT
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Usage-based
Starting from:
USD 1,500
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices
Supports Training Enablement:
Yes
Data Load Support Level:
Guided
Turnaround SLA:
Custom
eudamed_onboarding_support
eudamed_m2m
Jurisdictions:
EU
Countries:
DE, FR, GB
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
The EUDAMED.cloud solution includes features for staff training and testing in a playground environment, suggesting a focus on user onboarding and readiness.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor, UDI/Devices
Supports Actor Registration
Yes
Supports UDI
Yes
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