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), Unique Device Identification (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 and staff training environments.
* Facilitates EUDAMED data submission starting from May 2024.
* 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 compliance data.
**Reputation / proof points**
* Operates globally with listed office locations 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), Unique Device Identification (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 and staff training environments.
* Facilitates EUDAMED data submission starting from May 2024.
* 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 compliance data.
**Reputation / proof points**
* Operates globally with listed office locations in the United States, Australia, and the United Kingdom.
* Supports Healthcare Providers, Medical Device Suppliers, and GPOs & Distributors.
Additional information
Innovit's EUDAMED.cloud offers tiered pricing plans, with options including up to 100 or 200 UDI records and 4 named users. Features include templated data import/export (Excel/CSV), pre-configured review and approval workflows, and XML export for bulk uploads to EUDAMED. They also provide a 'playground' environment for staff training and testing EUDAMED data requirements. For UDI compliance, Innovit helps navigate evolving regional and country-specific regulations, addressing the complexity of submitting data to various regulators with different standards.
Key Highlights
-
Offers cloud-based solutions specifically for EUDAMED and UDI compliance.
Source
“Innovit provides cloud-based solutions for EUDAMED and UDI compliance”
-
Facilitates EUDAMED data submission from May 2024.
Source
“Go-live and submit your data to EUDAMED from May 2024”
-
Provides tools for managing and validating EUDAMED data, including templated import/export and approval workflows.
Source
“Manage & validate EUDAMED data Templated Data Import/Export (Excel/CSV) Pre-configured review & approval workflow”
-
Assists in navigating global UDI requirements and country-specific deadlines.
Source
“Innovit is here to to help you navigate these country-specific deadlines and UDI data requirements.”
Certifications & Trust Signals
-
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.”
-
Maintains 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 Level 5725 Martin PlaceSydney NSW 2000Australia 20–22 Wenlock RoadLondon N1-7GUUnited Kingdom”
Buyer Snapshot
Best for
- Medical device manufacturers needing EUDAMED and UDI compliance.
- Organizations seeking to manage and validate regulatory data for global markets.
- Healthcare providers and suppliers requiring streamlined compliance solutions.
How engagement typically works
- Cloud-based software solutions.
- Direct support for regulatory data management.
- Training and testing environments for compliance.
Typical deliverables
- EUDAMED compliance solutions.
- UDI data management and submission tools.
- Master Data Management (MDM) and Product Information Management (PIM) software.
- Global Data Synchronization Network (GDSN) hub.
Good to know
- Best when organizations require structured support for complex global regulatory data, particularly for EUDAMED and UDI.
Pricing
Model:
Usage-based
Public range:
Publicly listed: €150–€400 / month
Notes:
Based on publicly listed information for EUDAMED.cloud; final fees depend on scope and selected plan.
“Pricing: €150 per month; €250 per month; €400 per month”
HQ:
Austin, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Find 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 service includes templated data import/export, pre-configured review & approval workflow, and a playground environment for training and testing.
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
⚡ Instant booking available
Book EU EUDAMED Actor & UDI Setup Support
Compare Innovit and other vetted providers — instant pricing, no RFQ needed.
