I will handle eu mdr documentation eudamed registration and eu representative services

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Nadel

About this gig

Are you looking for professional assistance with EU MDR compliance, EUDAMED registration, or EU Authorized Representative guidance for your medical device?


You've come to the right place. I help medical device manufacturers, startups, and healthcare companies prepare the documentation and regulatory processes required under EU Medical Device Regulation (EU MDR 2017/745).


My Services Include:

  • EU Authorized Representative guidance
  • EUDAMED actor registration support
  • SRN (Single Registration Number) application guidance
  • EU MDR Technical Documentation
  • Technical File preparation
  • Clinical Evaluation Report (CER)
  • Risk Management File (ISO 14971)
  • Instructions for Use (IFU)
  • Label and Packaging Review
  • Declaration of Conformity (DoC)
  • Post-Market Surveillance (PMS) documentation
  • Post-Market Clinical Follow-up (PMCF)
  • Vigilance documentation


Why Choose Me?

  • Professional and confidential service
  • High-quality regulatory documentation
  • Timely delivery
  • Excellent communication
  • Customized solutions for your device classification


Contact me before placing an order so we can discuss your medical device, risk classification, and regulatory requirements to ensure the best solution for your project.

Get to know Nadel

Nadel

Medical Device Regulatory Affairs Specialist EU MDR and EUDAMED Expert

  • FromGermany
  • Member sinceJul 2026
  • Languages

    English
I am a Medical Device Regulatory Affairs Specialist with expertise in EU MDR (2017/745), EUDAMED registration, CE marking documentation, and regulatory compliance. I help medical device manufacturers, startups, and healthcare companies prepare accurate regulatory documentation that meets European Union requirements. My expertise includes: * EU MDR Technical Documentation * EUDAMED Actor Registration & SRN Guidance * CE Marking Documentation * Clinical Evaluation Report (CER) * Risk Management File (ISO 14971) * Post-Market Surveillance (PMS)