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Cumhur K.
@medexeurep
EU Authorised Representative and EUDAMED Registration
Turquia
Turco, Inglês
Sobre mim
I run Medex, a medical device regulatory firm in Ankara, Turkiye, working since 2020. We act as EU authorised representative under MDR/IVDR Article 11 (EUDAMED SRN TR-AR-000057550) and register manufacturers and devices in EUDAMED. We also draft EU declarations of conformity, review labels and IFUs, and handle device registration in Turkiye's national system with sworn Turkish translation. Everything is done remotely and in writing. Send me your device name, class and target market and I will tell you what applies.
Habilidades
Cumhur K.
offline •
Conheça meus serviços
Regulamentação de dispositivos médicos
I will register your medical device and company in eudamed
Regulamentação de dispositivos médicos
I will draft your mdr or ivdr eu declaration of conformity and review labels
