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 validation, training, and testing environments.
* Supports EUDAMED data submission from May 2024.
* Facilitates management and validation of EUDAMED data with templated import/export options (Excel/CSV) and XML export for bulk uploads.
* Assists with Unique Device Identification (UDI) compliance, addressing evolving regional and country-specific regulations.
* Offers a central hub for UDI resources, guidelines, and solutions for worldwide compliance.
**Reputation / proof points**
* Operates globally with 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 validation, training, and testing environments.
* Supports EUDAMED data submission from May 2024.
* Facilitates management and validation of EUDAMED data with templated import/export options (Excel/CSV) and XML export for bulk uploads.
* Assists with Unique Device Identification (UDI) compliance, addressing evolving regional and country-specific regulations.
* Offers a central hub for UDI resources, guidelines, and solutions for worldwide compliance.
**Reputation / proof points**
* Operates globally with 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 streamline compliance with EUDAMED data requirements. Key features include templated data import/export (Excel/CSV) and XML export for bulk uploads, enabling efficient data management and validation. The platform also provides a playground environment for staff training and testing. Pricing for EUDAMED.cloud is listed publicly, with options starting at €150 per month for basic features like up to 100 UDI records and 4 named users, scaling up for more extensive needs. Their UDI compliance services extend globally, helping manufacturers navigate diverse country-specific regulations and data submission mandates.
Key Highlights
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Offers a cloud-based EUDAMED compliance solution with features for data validation and submission.
Source
“We have all the tools you need to prepare for EUDAMED compliance”
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Provides tools for training and testing staff in a dedicated EUDAMED playground environment.
Source
“Train and test your staff in Innovit’s EUDAMED playground environment”
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Supports EUDAMED data submission starting from May 2024.
Source
“Go-live and submit your data to EUDAMED from May 2024”
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Facilitates UDI compliance globally, addressing diverse country-specific regulations and data requirements.
Source
“Global medical device manufacturers are required to submit UDI data to a variety of country-specific regulators”
Certifications & Trust Signals
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Innovit has 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 suppliers needing EUDAMED and UDI compliance solutions.
- Healthcare providers managing regulatory data.
- Companies operating internationally with multi-country UDI requirements.
How engagement typically works
- Cloud-based software solutions.
- Direct sales and support engagement.
Typical deliverables
- EUDAMED data validation and submission support.
- UDI compliance management tools.
- Regulatory data import/export functionalities.
- Training and testing environments for EUDAMED.
Good to know
- Best when seeking cloud-based, specialized regulatory compliance software.
Pricing
Model:
Usage-based
Public range:
Publicly listed: €150 - €400 per month
Notes:
Based on publicly listed information for EUDAMED.cloud; final fees depend on scope and specific plan.
“Pricing: €150 per month; €250 per month; €400 per month”
HQ:
Austin, US
Languages:
English
Timezones:
America/New_York
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 structured onboarding process focused on user familiarization and data preparation.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices
Supports Actor Registration
Yes
Supports UDI
Yes
