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clara_james_t

Clara james

@clara_james_t

Bridging the Gap Between Innovation and Global Medical Compliance

United Kingdom
English, French
About me
Dedicated Medical Compliance Specialist with a focus on ISO 13485 and EU MDR/FDA frameworks. I help medical device manufacturers navigate complex regulatory landscapes through robust QMS documentation, technical file preparation, and audit readiness. My goal is to streamline your path to certification so you can focus on life-saving innovation.... Read more

Skills

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clara_james_t
Clara james
Offline • 
Average response time: 10 hours

See my services

Digital Marketing
I will do fda medical device compliance, mhra registration and ukca certification
Business Strategy & Innovation
I will prepare fda medical device premarket submissions and 510k documentation