Parcourir les catégories
Explorer
Fiverr Pro
Français
$
USD
Ethan Coles
@ethancolles
Medical Device Regulatory Consultant
Royaume-Uni
Anglais
À propos de moi
Hi, I’m Ethan Coles, a medical device regulatory consultant with hands-on experience supporting startups, manufacturers, and innovators through the full compliance process from early documentation to complete FDA 510(k) submissions and EU MDR requirements. I help companies bring safe, compliant devices to market by preparing clear, accurate regulatory documentation that meets FDA, EU MDR, ISO 14971, and GMP expectations. I take a practical, detail-focused approach no templates, no guesswork. Let’s get your device closer to market approval with documentation that stands up to regulatory review.
Compétences
Ethan Coles
hors ligne •
Temps de réponse moyen de 342 heures
Voir mes services
Réglementation des dispositifs médicaux
I will prepare fda 510k submission, premarket notification docs, regulatory compliance
Réglementation des dispositifs médicaux
I will create eu mdr technical file, ce marking documentation, conformity dossier prep
