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Ethan Coles
@ethancolles
Medical Device Regulatory Consultant
Großbritannien
Englisch
Über mich
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.
Kompetenzen
Ethan Coles
offline •
Durchschnittliche Antwortzeit: 342 Stunden
Meine Dienstleistungen
Regulierung für Medizinprodukte
I will prepare fda 510k submission, premarket notification docs, regulatory compliance
Regulierung für Medizinprodukte
I will create eu mdr technical file, ce marking documentation, conformity dossier prep
