Europe IT Consulting
Europe IT Consulting GmbH
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About
**Who they are**
Europe IT Consulting GmbH is an ISO 9001 certified company and SAP Partner specializing in software development and UDI consulting for medical device companies. They focus on helping businesses navigate the complexities of EUDAMED and UDI data submission.
**Expertise & scope**
* Expertise in EUDAMED database setup and understanding its modules (ACT, UDI, CRF, CIPS, VGL, MSU).
* Guidance on MDR and IVDR compliance, particularly concerning UDI data transfer and EUDAMED requirements.
* Consulting on UDI data submission strategies, including options like Excel templates, Global Submission Portals, and SAP Add-ons.
* Development of resources such as UDI guides, error libraries for reducing rejections, and evidence packs for audit preparedness.
* Support for ensuring data quality, traceability, and transparency in the EU market for medical devices.
**Reputation / proof points**
* ISO 9001 certified company.
* SAP Partner.
Europe IT Consulting GmbH is an ISO 9001 certified company and SAP Partner specializing in software development and UDI consulting for medical device companies. They focus on helping businesses navigate the complexities of EUDAMED and UDI data submission.
**Expertise & scope**
* Expertise in EUDAMED database setup and understanding its modules (ACT, UDI, CRF, CIPS, VGL, MSU).
* Guidance on MDR and IVDR compliance, particularly concerning UDI data transfer and EUDAMED requirements.
* Consulting on UDI data submission strategies, including options like Excel templates, Global Submission Portals, and SAP Add-ons.
* Development of resources such as UDI guides, error libraries for reducing rejections, and evidence packs for audit preparedness.
* Support for ensuring data quality, traceability, and transparency in the EU market for medical devices.
**Reputation / proof points**
* ISO 9001 certified company.
* SAP Partner.
Additional information
Europe IT Consulting offers practical resources to aid regulatory affairs and quality assurance professionals. Their UDI Ratgeber provides decision-making tools, a library of common errors with solutions, and guidance on creating evidence packs for audits. They emphasize the importance of standardized processes for UDI data management, submission, and proof of compliance, offering different approaches from Excel to integrated SAP solutions to meet varying company needs and ensure audit-readiness.
Key Highlights
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Specializes in EUDAMED database setup and UDI consulting for medical devices.
Source
“Software Development & UDI Consulting”
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Provides a UDI Ratgeber including decision aids, an error library, and an evidence pack guide.
Source
“Dieser Ratgeber richtet sich an Regulatory Affairs & Quality (RA/QA), die UDI-Daten zuverlässig vorbereiten, einreichen und audit-sicher nachweisen müssen”
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Offers guidance on different UDI data transfer methods: Excel, Global Submission Portal, and SAP Add-on.
Source
“Excel vs Global Submission Portal vs GUDI Add-on”
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Focuses on ensuring data quality, reducing rejections, and providing audit evidence for submissions.
Source
“Ein Audit scheitert selten daran, dass „nichts eingereicht wurde“. Es scheitert daran, dass Sie nicht konsistent nachweisen können”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers needing EUDAMED and UDI compliance support.
- Companies seeking guidance on UDI data submission strategies and error reduction.
- Organizations requiring assistance with audit evidence preparation for UDI submissions.
How engagement typically works
- Consulting and advisory services.
- Provision of practical guides and tools.
- Software development and integration support.
Typical deliverables
- EUDAMED setup guidance.
- UDI data submission strategy.
- UDI Ratgeber (guides, error library, evidence pack templates).
- Software development for compliance needs.
Good to know
- Best when companies are preparing for or actively managing EUDAMED and UDI compliance under MDR/IVDR.
HQ:
Zurich, US
Languages:
English, German, French
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
NL, ES, SE, BE, FR, DE, AT
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–30 days
Pricing model:
Custom pricing
Starting from:
CHF 1,800
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Modules Supported:
Actor/SRN, UDI/Devices, Vigilance
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
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 company provides resources and consulting to assist with EUDAMED setup and UDI data submission, including guidance on choosing the right submission method (Excel, Portal, SAP Add-on) and preparing necessary documentation for audits.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
ACT, UDI/Devices, Vigilance, Clinical Investigations, Certificates & Notifications (implied by EUDAMED focus)
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
Yes
