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Pluus
@bplussolutions
EU MDR Regulatory Specialist CER and Technical Documentation Review
Turchia
Inglese, Turco
Chi sono
I am an EU MDR Regulatory Specialist with over 10 years of experience in medical device compliance, clinical evaluation (CER), and technical documentation review. My work focuses on MDR Annex II & III assessments, CER compliance reviews, and structured gap analysis aligned with EU MDR requirements.
I have worked at medical device manufacturers and experience working at Notified Body side, giving me insight from both sides of the regulatory process. I provide independent, objective MDR compliance evaluations to reduce potential findings before submission.
Competenze
Pluus
offline •
Tempo di risposta medio: 12 ore
Consulta i miei servizi
Scrittura tecnica
I will review medical device mdr technical documentation
