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Adele Samson
@adele_samson
FDA Medical Device and Regulatory Compliance Specialist
Estados Unidos
Inglês
Sobre mim
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.
Habilidades
Adele Samson
offline •
Tempo médio de resposta: 3 horas
Conheça meus serviços
Regulamentação de dispositivos médicos
I will handle fda 510k submission, device listing, ndc, fda registration and compliance
Autorização de segurança alimentar e da FDA
I will do fda food facility registration and provide US agent service
