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Nadel
@nadel_tom
Medical Device Regulatory Affairs Specialist EU MDR and EUDAMED Expert
Germania
Inglese
Chi sono
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)
Competenze
Nadel
offline •
Consulta i miei servizi
Regolamentazione per dispositivi medici
I will handle eu mdr documentation eudamed registration and eu representative services
