Europe IT Consulting
Europe IT Consulting GmbH
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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 compliance for medical device manufacturers. They are an ISO 9001 certified company and an SAP Partner.
**Expertise & scope**
* Assistance with EUDAMED setup and understanding its modules.
* Guidance on UDI data transfer and implementation requirements under MDR and IVDR.
* Consulting on various UDI submission methods, including Excel, Global Submission Portal, and SAP Add-on.
* Development of UDI Evidence Packs for audit readiness.
* Support in improving data quality and streamlining submissions.
* Information on EUDAMED rollout plans and transition periods.
**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 compliance for medical device manufacturers. They are an ISO 9001 certified company and an SAP Partner.
**Expertise & scope**
* Assistance with EUDAMED setup and understanding its modules.
* Guidance on UDI data transfer and implementation requirements under MDR and IVDR.
* Consulting on various UDI submission methods, including Excel, Global Submission Portal, and SAP Add-on.
* Development of UDI Evidence Packs for audit readiness.
* Support in improving data quality and streamlining submissions.
* Information on EUDAMED rollout plans and transition periods.
**Reputation / proof points**
* ISO 9001 certified company.
* SAP Partner.
Additional information
Europe IT Consulting provides practical resources to navigate EUDAMED and UDI compliance. Their UDI Ratgeber offers decision-making tools, a library of common errors with solutions, and an Evidence Pack guide. They emphasize the importance of data quality, auditability, and standardized processes for successful submissions. Buyers can leverage their expertise to choose the most suitable submission method (Excel, Portal, or SAP Add-on) based on their specific needs and team capabilities, aiming to reduce rework and ensure compliance.
Key Highlights
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Specializes in EUDAMED setup and UDI consulting for medical devices.
Source
“EUDAMED | Aufbau der European Database for Medical Devices”
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Offers guidance on UDI data transfer options including Excel, Global Submission Portal, and SAP Add-on.
Source
“Excel vs Global Submission Portal vs GUDI Add-on”
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Provides resources for audit readiness with UDI Evidence Packs.
Source
“UDI Evidence Pack: Welche Audit-Nachweise RA/QA für Einreichungen braucht”
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ISO 9001 certified company and SAP Partner.
Source
“ISO 9001 certified company; Wir sind SAP Partner”
Certifications & Trust Signals
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ISO 9001 certified company.
Source
“ISO 9001 certified company”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EUDAMED and UDI compliance support.
- Companies needing guidance on data quality and submission processes.
How engagement typically works
- Consulting on EUDAMED setup and UDI implementation.
- Provision of practical guides and tools for compliance.
Typical deliverables
- EUDAMED setup guidance.
- UDI data transfer strategy.
- UDI Evidence Pack documentation.
- Recommendations on submission methods (Excel, Portal, SAP Add-on).
Good to know
- Best when a structured approach to UDI data management and EUDAMED submission is required.
HQ:
Zurich, US
Languages:
English, German, French
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Find 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
Information on EUDAMED rollout plans and transition periods, including timelines for module publication and onboarding. Guidance on choosing submission methods (Excel, Portal, SAP Add-on) and preparing UDI data.
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 through EUDAMED focus)
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
Yes
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