Eudamed.com

Eudamed.com offers specialized online training for EUDAMED, covering actor registration, device data, and data submission requirements. Learn from experts who developed the system.

Eudamed.com provides comprehensive online self-paced training designed to guide users through the complexities of the EUDAMED system. Leveraging the expertise of individuals who were part of the European Commission teams that created EUDAMED, this training covers essential aspects such as actor registration for your SRN and device data management. The curriculum is structured to teach you how to prepare your data for uploads, navigate the web-based EUDAMED input forms, and understand the specific data requirements. Key modules include an introduction to EUDAMED, understanding XSDs and data submissions, data exchange, machine-to-machine access, message encapsulation, actor registration and user management, UDI device registration, and EC publications. This training is essential for anyone embarking on a EUDAMED project, ensuring you have all the necessary knowledge to get started effectively.

About

**Who they are**
Eudamed.com provides specialized online training focused on the EUDAMED system. They aim to equip users with the knowledge required for navigating EUDAMED regulations and data submission processes.

**Expertise & scope**
* Training on actor registration and obtaining a Single Registration Number (SRN).
* Guidance on device data management within EUDAMED.
* Instruction on data submission requirements for medical devices.
* Content developed by individuals involved in the system's creation.

**Reputation / proof points**
* Coverage across the European Union.
* Training materials available in English, French, German, and Spanish.

Additional information

Eudamed.com's training programs are designed to demystify the complexities of EUDAMED compliance. Their self-paced online courses offer flexibility for professionals needing to understand actor registration, device data management, and submission protocols. The training emphasizes practical application, drawing from the expertise of those who contributed to the development of the EUDAMED system itself. This unique perspective ensures that learners receive insights directly relevant to the system's intended use and regulatory framework.

Key Highlights

  • Offers specialized online training for EUDAMED. Source
    “Eudamed.com offers specialized online training for EUDAMED, covering actor registration, device data, and data submission requirements.”
  • Training content developed by system creators. Source
    “Learn from experts who developed the system.”
  • Provides training in English, French, German, and Spanish. Source
    “Languages: English, French, German, Spanish”

Certifications & Trust Signals

  • Training developed by experts involved in the EUDAMED system. Source
    “Learn from experts who developed the system.”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking to understand EUDAMED requirements.
  • Regulatory affairs professionals needing to register actors and devices.
  • Companies preparing for EUDAMED data submission.
How engagement typically works
  • Self-paced online training modules.
  • Expert-led instruction.
Typical deliverables
  • Online training courses.
  • Knowledge on actor registration.
  • Guidance on device data management.
  • Understanding of data submission processes.
Good to know
  • Best when focused on understanding EUDAMED system functionalities and compliance.
HQ: Brussels, EU
Languages: English, French, German, Spanish
Timezones: CET, GMT
Status: listed

Services & Capabilities

EUDAMED Onboarding & Data Registration Support (Mandatory Modules)

Jurisdictions: EU
Countries: Belgium, France, Germany, Spain
Industries: Medical Devices, IVD
Pricing model: Custom pricing
Modules Supported: Actor/SRN, UDI/Devices
Submission Approach: Portal, Bulk Submissions, M2M Integration

Additional eudamed_onboarding_support Details

Modules Supported
Actor/SRN, UDI/Devices
Submission Approach
Portal operations (implied through training on data submission)
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