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Adele Samson
@adele_samson
FDA Medical Device and Regulatory Compliance Specialist
Stati Uniti
Inglese
Chi sono
I am a regulatory affairs specialist with years of experience helping medical device startups and manufacturers navigate the FDA 510(k) submission process. I specialize in medical device classification, predicate device identification, substantial equivalence, and labeling compliance under 21 CFR 801.
I have successfully prepared over 50 FDA submissions with a 100% acceptance rate. My approach is thorough and focused on efficient clearance.
Contact me to get your medical device FDA cleared.
Competenze
Adele Samson
offline •
Tempo di risposta medio: 1 ora
Consulta i miei servizi
Regolamentazione per dispositivi medici
I will prepare your fda medical device 510k submission report
FDA e autorizzazione alla sicurezza alimentare
I will handle fda cfia mhra ema product compliance USA canada eu
