Innovit

Innovit provides cloud-based solutions for managing, validating, and exchanging product data to ensure regulatory compliance, particularly for EUDAMED and UDI requirements in healthcare.

Innovit specializes in simplifying the complex process of managing and validating product data for regulatory compliance, with a strong focus on EUDAMED and UDI requirements in the healthcare and life sciences sectors. Their GDSN.cloud and EUDAMED.cloud solutions empower medical device manufacturers and suppliers to meet stringent global regulations, reduce procurement spend, and improve supply chain analytics. With upcoming deadlines for EUDAMED and Australian AusUDID, Innovit offers tools to gain visibility into data requirements, train staff, and submit validated data. They provide user-friendly, certified GDSN solutions and dedicated platforms to manage, validate, and exchange accurate regulatory data, ensuring compliance with agencies like the FDA and European Commission. Innovit's offerings include Product Information Management, Global Data Syndication Hub, UDI Compliance, and Multi-domain MDM, helping organizations improve data quality, meet UDI data compliance, and drive supply chain efficiencies. They serve Healthcare Providers, Medical Device Suppliers, and GPOs & Distributors, assisting them in navigating evolving country-specific regulations and data sharing requirements.

About

**Who they are**
Innovit is a global solution provider specializing in Master Data Management (MDM), Product Information Management (PIM), Global Data Synchronization (GDSN), Unique Device Identification (UDI) Compliance, and NPI Workflow Automation software. They offer cloud-based solutions designed to manage, validate, and exchange product data, ensuring regulatory compliance, particularly for EUDAMED and UDI requirements in the healthcare sector.

**Expertise & scope**
* Provides tools to prepare for EUDAMED compliance, including data management, validation, and submission capabilities.
* Offers a EUDAMED playground environment for staff training and testing.
* Facilitates data submission to EUDAMED starting from May 2024, with a fully functional system released in January 2026.
* Supports UDI compliance for various global regulations, including the US FDA's GUDID and the EU's MDR EUDAMED.
* Specializes in managing and exchanging accurate regulatory data for global compliance and patient safety.
* Offers solutions for NPI Workflow Automation.

**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.
* A large customer has submitted over 95,000 records to EUDAMED.

Additional information

Innovit's EUDAMED.cloud solution offers tiered pricing plans, with options including up to 100 or 200 UDI records and 4 named users. Features include templated data import/export via Excel/CSV, pre-configured review and approval workflows, and XML export for bulk uploads to EUDAMED. They also provide a GUDID.cloud solution for US FDA UDI compliance. For those navigating global UDI requirements, Innovit acts as a central hub for resources, guidelines, and solutions to achieve compliance worldwide, helping to manage country-specific deadlines and data requirements.

Key Highlights

  • Innovit provides a EUDAMED playground for staff training and testing of compliance workflows. Source
    “Train and test your staff in Innovit’s EUDAMED playground environment”
  • Offers tiered pricing for EUDAMED compliance, starting at €150 per month. Source
    “Pricing: €150 per month; €250 per month; €400 per month”
  • Supports EUDAMED data submission from May 2024, with a fully functional system by January 2026. Source
    “Go-live and submit your data to EUDAMED from May 2024”
  • Innovit offers solutions for both EUDAMED (EU) and GUDID (US) regulatory requirements. 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).”

Certifications & Trust Signals

  • Innovit 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 Level 5725 Martin PlaceSydney NSW 2000Australia 20–22 Wenlock RoadLondon N1-7GUUnited Kingdom”
  • A significant customer is submitting over 95,000 records to EUDAMED. Source
    “Largest customer submitting 95K+ records to EUDAMED.”

Buyer Snapshot

Best for
  • Medical device manufacturers needing EUDAMED and UDI compliance solutions.
  • Companies seeking to manage, validate, and exchange product data for regulatory adherence.
How engagement typically works
  • Direct sales engagement for solution discussion.
  • Provision of cloud-based software solutions.
Typical deliverables
  • EUDAMED compliance software and support.
  • UDI data management and submission tools.
  • Product Information Management (PIM) solutions.
  • Global Data Synchronization Hub (GDSN) services.
Good to know
  • Best when organizations require structured data management for regulatory compliance, particularly in the healthcare and life sciences sectors.

Pricing

Model: Flat subscription
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 selected.
“Pricing: €150 per month; €250 per month; €400 per month”
HQ: Austin, US
Languages: English
Timezones: UTC-6, UTC-5, UTC-8, UTC-7
Status: listed

Services & Capabilities

EUDAMED M2M Integration

Pricing model: Flat subscription
Supported Modules: UDI/Devices
Provides Access Point: Yes
Provides Sandbox: Yes

Additional eudamed_m2m Details

Supported Modules
UDI/Devices (EUDAMED)
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