TÜV SÜD

★★★★★ 3.3 / 5
204 reviews

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 Academy – EUDAMED Training provides specialized training to support medical device manufacturers in navigating regulatory compliance. They focus on equipping professionals with the knowledge needed for EUDAMED.

**Expertise & scope**
* Offers comprehensive EUDAMED training programs.
* Aims to support regulatory compliance for medical device manufacturers.
* Coverage extends to the European Union (EU).
* Training is available in English and German.

**Reputation / proof points**
* Provider Name: TÜV SÜD Academy – EUDAMED Training
* Geographic Coverage: EU
* Languages Offered: English, German

Additional information

This provider focuses on educational services to facilitate EUDAMED compliance. Their training is designed for medical device manufacturers seeking to understand and implement the necessary regulatory steps. Consider their offerings if your team requires structured learning on EUDAMED requirements, with options for both English and German language instruction. The training aims to build internal expertise for ongoing compliance management within the EU regulatory framework.

Key Highlights

  • Offers EUDAMED training to support regulatory compliance for medical device manufacturers. Source
    “TÜV SÜD Academy offers EUDAMED training, supporting regulatory compliance for medical device manufacturers.”
  • Training is available in English and German. Source
    “Languages: English, German”
  • Coverage for the European Union (EU). Source
    “Coverage: EU”

Certifications & Trust Signals

  • Operates within the EU regulatory landscape. Source
    “Coverage: EU”

Buyer Snapshot

Best for
  • Medical device manufacturers needing EUDAMED training
  • Companies seeking to understand EU medical device regulations
How engagement typically works
  • Training programs
  • Educational support
Typical deliverables
  • EUDAMED compliance knowledge
  • Regulatory training materials
Good to know
  • Best when focused on learning and internal capacity building for EUDAMED
HQ: Munich, Germany
Languages: English, German
Timezones: Europe/Brussels
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
Supports Actor Registration
No explicit mention, focus is on training.
Supports UDI
No explicit mention, focus is on training.
Supports Vigilance
No explicit mention, focus is on training.
Supports Clinical Investigations
No explicit mention, focus is on training.
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