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ethancolles

Ethan Coles

@ethancolles

Medical Device Regulatory Consultant

United Kingdom
English
About me
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.... Read more

Skills

e
ethancolles
Ethan Coles
Offline • 
Average response time: 342 hours

See my services

Medical Device Regulatory
I will prepare fda 510k submission, premarket notification docs, regulatory compliance
From$150 / projectMore details
Medical Device Regulatory
I will create eu mdr technical file, ce marking documentation, conformity dossier prep
From$150 / projectMore details