TÜV SÜD
TÜV SÜD is a leading testing, inspection, and certification company providing comprehensive medical device services including EUDAMED registration support, UDI compliance, and regulatory services. They offer both certification services and training programs for medical device manufacturers.
TÜV SÜD Academy is a specialized provider of training services focused on EUDAMED (European Database on Medical Devices). They equip professionals and organizations with the knowledge and skills necessary to navigate the complex regulatory landscape of medical devices within the EU. Their training programs are designed to ensure compliance with EUDAMED requirements, facilitating smoother market access and operational efficiency for manufacturers. This focus makes them a key resource for companies seeking to understand and implement EUDAMED regulations effectively.
About
**Who they are**
TÜV SÜD is a globally recognized testing, inspection, and certification company. They offer a comprehensive suite of services for medical device manufacturers navigating complex regulatory landscapes.
**Expertise & scope**
* EUDAMED registration support
* UDI compliance and implementation
* Broader regulatory services for medical devices
* Certification services
* Training programs for medical device professionals
**Reputation / proof points**
* Operates across the European Union (EU)
* Services available in English and German
TÜV SÜD is a globally recognized testing, inspection, and certification company. They offer a comprehensive suite of services for medical device manufacturers navigating complex regulatory landscapes.
**Expertise & scope**
* EUDAMED registration support
* UDI compliance and implementation
* Broader regulatory services for medical devices
* Certification services
* Training programs for medical device professionals
**Reputation / proof points**
* Operates across the European Union (EU)
* Services available in English and German
Additional information
When engaging TÜV SÜD for EUDAMED support, manufacturers can expect a structured approach to compliance. Their services extend beyond just registration, encompassing the full lifecycle of UDI compliance and other critical regulatory requirements. The company's dual focus on certification and training aims to equip manufacturers with both the necessary approvals and the in-house knowledge to maintain compliance independently. Engagement typically involves detailed consultations to understand specific product portfolios and target markets within the EU, ensuring tailored support for each client's unique situation.
Key Highlights
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Provides comprehensive medical device services including EUDAMED registration support.
Source
“comprehensive medical device services including EUDAMED registration support”
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Offers UDI compliance and broader regulatory services.
Source
“UDI compliance, and regulatory services”
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Delivers both certification services and training programs.
Source
“offer both certification services and training programs”
Certifications & Trust Signals
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A leading testing, inspection, and certification company.
Source
“a leading testing, inspection, and certification company”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EUDAMED registration support
- Companies needing UDI compliance solutions
- Organizations requiring broader medical device regulatory guidance
How engagement typically works
- Consultative approach to regulatory challenges
- Provision of certification and training services
- Support for EU market access
Typical deliverables
- EUDAMED registration assistance
- UDI implementation guidance
- Regulatory strategy advice
- Training materials and sessions
Good to know
- Best when requiring comprehensive regulatory support beyond just EUDAMED
- Best when seeking a globally recognized certification body
HQ:
Munich, Germany
Languages:
English, German
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
IT, DE, NL, PL, SE, ES
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
1–10 days
Pricing model:
Per project
Starting from:
EUR 750
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices
Supports Training Enablement:
Yes
Data Load Support Level:
Training only
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
No explicit mention of onboarding process, focus is on training content.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
EUDAMED registration support implies support for relevant modules, likely including Actor, UDI/Devices.
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
No explicit mention, focus is on training.
Supports Clinical Investigations
No explicit mention, focus is on training.
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