j
joshuu8

Joshua

@joshuu8

Medical Device Regulatory Affairs Specialist, FDA, EU MDR, IVDR, MHRA, SFDA

Vereinigte Staaten
Englisch, Französisch
Einige Informationen werden in englischer Sprache angezeigt.
Über mich
Are you struggling to get your medical device approved in the US, EU, or UK? I help manufacturers, startups, and distributors successfully navigate FDA 510(k), CE Marking (EU MDR/IVDR), and UKCA compliance without delays, rejections, or costly mistakes. With hands on experience in regulatory documentation and submission strategy, I support you with: 510(k) submission preparation EU MDR / IVDR Technical Documentation Clinical Evaluation Reports Risk Management (ISO 14971) ISO 13485 I focus on accuracy, compliance, and fast turnaround, ensuring your product meets global regulatory standards.... Mehr lesen

Kompetenzen

j
joshuu8
Joshua
offline • 
Durchschnittliche Antwortzeit: 4 Stunden

Meine Dienstleistungen

Einhaltung von Umweltvorschriften
I will do fda 510k eu mdr ivdr mhra sfda medical device compliance
Ab40 $ / ProjektWeitere Details
Unternehmens- & Handelsverträge
I will help with fda 510k ce marking eu mdr ivdr medical device compliance
Ab50 $ / ProjektWeitere Details

Arbeitserfahrung

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Jan 2024 - Present • 2 yrs 4 mos

Assisted medical device companies with FDA and EU MDR compliance Prepared technical documentation Supported CE Marking submissions Conducted regulatory gap analysis Prepared regulatory strategies