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Adele Samson
@adele_samson
FDA Medical Device and Regulatory Compliance Specialist
États-Unis
Anglais
À propos de moi
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.
Compétences
Adele Samson
hors ligne •
Temps de réponse moyen de 3 heures
Voir mes services
Réglementation des dispositifs médicaux
I will handle fda 510k submission, device listing, ndc, fda registration and compliance
Habilitation FDA et sécurité alimentaire
I will do fda food facility registration and provide US agent service
