Europe IT Consulting
Europe IT Consulting GmbH
Boston Consulting Group (BCG) is a global management consulting firm that helps clients in various industries drive competitive advantage through strategic insights and innovative solutions. They specialize in areas like digital transformation, pricing, and revenue growth management.
Boston Consulting Group (BCG) is a premier global management consulting firm renowned for its strategic advisory services. They partner with organizations across diverse sectors, including Aerospace and Defense, Automotive, Consumer Products, Energy, Financial Institutions, and Healthcare, to enhance competitiveness and foster innovation. BCG offers specialized expertise in critical business functions such as Pricing and Revenue Management, B2B and B2C Pricing strategies, and Revenue Growth Management. Their approach leverages deep industry knowledge, data analytics, and AI to develop practical, equitable, and transformative solutions tailored to client needs. With a commitment to driving fundamental change and delivering on evolving customer demands, BCG empowers clients to navigate complex market dynamics, embrace digital advancements, and achieve sustainable growth. Their work focuses on creating value through strategic insights, operational improvements, and a forward-looking perspective on industry trends.
About
**Who they are**
Europe IT Consulting GmbH is a company specializing in software development and UDI consulting, with a focus on EUDAMED. They are an ISO 9001 certified company and an SAP Partner.
**Expertise & scope**
* Expertise in EUDAMED database setup and data management for medical devices.
* Consulting on UDI (Unique Device Identification) implementation, including data transfer, UDI guidance, and evidence packs.
* Identification and proposal of improvements for EUDAMED architecture, specifically addressing data management conflicts related to UDI-DI and market information updates.
* Guidance on EUDAMED rollout plans, including timelines for module releases and transition periods.
* Support for MedTech manufacturers in improving data quality, streamlining submissions, and operationalizing UDI solutions.
**Reputation / proof points**
* ISO 9001 certified company.
* SAP Partner.
Europe IT Consulting GmbH is a company specializing in software development and UDI consulting, with a focus on EUDAMED. They are an ISO 9001 certified company and an SAP Partner.
**Expertise & scope**
* Expertise in EUDAMED database setup and data management for medical devices.
* Consulting on UDI (Unique Device Identification) implementation, including data transfer, UDI guidance, and evidence packs.
* Identification and proposal of improvements for EUDAMED architecture, specifically addressing data management conflicts related to UDI-DI and market information updates.
* Guidance on EUDAMED rollout plans, including timelines for module releases and transition periods.
* Support for MedTech manufacturers in improving data quality, streamlining submissions, and operationalizing UDI solutions.
**Reputation / proof points**
* ISO 9001 certified company.
* SAP Partner.
Additional information
Europe IT Consulting GmbH provides resources such as a UDI guide, which includes decision aids, a library of common errors, and an evidence pack to help regulatory affairs and quality assurance professionals prepare, submit, and audit UDI data reliably. They offer different approaches for UDI data submission, including Excel templates, submission portals, and SAP add-ons, with comparative tables and project plans available. Their services aim to reduce submission errors and accelerate corrections.
Key Highlights
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Europe IT Consulting GmbH identifies and proposes solutions for critical issues in EUDAMED data management, such as conflicts in updating UDI-DI and market information.
Source
“Die Experten der Europe IT Consulting GmbH haben eine signifikante Schwachstelle in der EUDAMED-Architektur identifiziert, die die Datenpflege für Medizintechnik-Unternehmen erheblich erschwert.”
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They provide a UDI Ratgeber (UDI Guide) that includes decision aids, a library of common errors, and an evidence pack for reliable UDI data preparation and submission.
Source
“Dieser Ratgeber richtet sich an Regulatory Affairs & Quality (RA/QA), die UDI-Daten zuverlässig vorbereiten, einreichen und audit-sicher nachweisen müssen – ohne unnötige Schleifen.”
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The company offers consulting on EUDAMED setup, UDI data transfer, and provides insights into the EUDAMED rollout plan, including updated timelines for 2025-2027.
Source
“Die Europäische Kommission hat den EUDAMED-Rollout-Plan erneut aktualisiert und dabei einige Änderungen an der Einführung und den Übergangsfristen vorgenommen.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers navigating EUDAMED requirements.
- Companies seeking to streamline UDI data management and submissions.
- Organizations needing guidance on EUDAMED rollout timelines and compliance.
How engagement typically works
- Consulting on EUDAMED setup and data management.
- Support for UDI implementation and data transfer.
- Providing practical guides and tools for regulatory compliance.
Typical deliverables
- EUDAMED data management strategy.
- UDI submission process optimization.
- UDI data quality improvement plans.
- Guidance on EUDAMED module integration.
Good to know
- Best when requiring specialized EUDAMED and UDI consulting services.
HQ:
Zurich, US
Languages:
English, German, French
Timezones:
Europe/Brussels
Claim 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 like a UDI guide and offers solutions for data submission, suggesting a process involving assessment, data preparation, and submission.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices, Vigilance, Market Surveillance, Certificates (implied by rollout plan)
Supports Actor Registration
Implied through general EUDAMED support
Supports UDI
Yes
Supports Vigilance
Yes (mentioned in rollout plan)
Supports Clinical Investigations
No explicit mention
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