Europe IT Consulting GmbH

UDI software and submission solutions for medical device manufacturers, including GSP, GUDI for SAP, data validation, and EUDAMED M2M/data exchange.

Europe IT Consulting GmbH provides UDI software and submission solutions for medical device and IVD manufacturers. Its Global Submission Portal (GSP) supports structured UDI data validation and submission workflows. GUDI supports UDI data management, validation, approval, submission status, and authority feedback within SAP. Europe IT operates the gateway/access point used by these solutions for EUDAMED M2M/data exchange. The company's submission coverage includes EUDAMED, swissdamed, FDA GUDID, and TGA AusUDID. Public pricing is not listed; prospective customers should contact Europe IT for a quote.

About

Europe IT Consulting GmbH provides UDI software and submission solutions for medical device and IVD manufacturers.

Its Global Submission Portal (GSP) supports structured UDI data validation and submission workflows. GUDI supports UDI data management, validation, approval, submission status, and authority feedback within SAP. Europe IT operates the gateway/access point used by these solutions for EUDAMED M2M/data exchange.

The company's submission coverage includes EUDAMED, swissdamed, FDA GUDID, and TGA AusUDID. Public pricing is not listed; prospective customers should contact Europe IT for a quote.

Additional information

Customers can use the Global Submission Portal (GSP) for an Excel-based workflow or GUDI for an SAP-integrated workflow. Both support validation before submission, status tracking, authority feedback, and customer-controlled corrections and resubmissions.

Key Highlights

  • Global Submission Portal for Excel-based UDI validation and submission workflows Source
    “Europe IT Consulting offers this submission process through the Global Submission Portal (GSP) and GUDI, the UDI solution for SAP.”
  • GUDI for UDI data management and submission workflows in SAP Source
    “With GUDI, you maintain and validate UDI data in SAP and trigger submission directly from GUDI.”
  • Europe IT operates the gateway/access point used for EUDAMED M2M/data exchange Source
    “Europe IT operates the access point or gateway used for this purpose.”
  • Submission coverage includes EUDAMED, swissdamed, FDA GUDID, and AusUDID Source
    “Global UDI Submission Portal”

Certifications & Trust Signals

  • Europe IT states that it is ISO 9001 certified and an SAP Partner. Source
    “ISO 9001 certified company. We are SAP Partner.”

Buyer Snapshot

Best for
  • Medical device and IVD manufacturers managing UDI submissions
  • Teams that need EUDAMED M2M/data exchange through a managed access point
  • Companies choosing between Excel-based and SAP-integrated UDI workflows
How engagement typically works
  • Global Submission Portal onboarding and support
  • GUDI implementation for SAP-based UDI workflows
  • EUDAMED M2M/access-point onboarding
Typical deliverables
  • Validated, submission-ready UDI data
  • Submissions to EUDAMED, swissdamed, FDA GUDID, and AusUDID
  • Submission status and authority-feedback workflows
  • Access-point/gateway onboarding documentation
Good to know
  • Public pricing is not listed; contact Europe IT for a quote.

Pricing

Model: Custom pricing
Public range: Contact for quote
Notes: No verified public price is listed.
HQ: Basel, Switzerland
Languages: English, German
Timezones: Europe/Zurich
Claim status: Claimed

Services & Capabilities

EUDAMED M2M Integration

Jurisdictions: EU, CH, US, AU
Industries: Medical devices, IVD, SaMD, Manufacturing
Portfolio: 1-5, 6-25, 26-100, 100+
Pricing model: Custom pricing
Included services: Global Submission Portal (GSP), GUDI - UDI solution for SAP, UDI data validation, EUDAMED M2M / data exchange, Access-point / gateway services, EUDAMED submissions, swissdamed submissions, FDA GUDID submissions, TGA AusUDID submissions
Supported Modules: UDI/Devices
Provides Access Point: Yes
Request a Quote
Cruxi - Regulatory Compliance Services