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Hughes Helen
@hugheshelen
Regulatory Writer, Medical Device Compliance Specialist
Verenigd Koninkrijk
Spaans, Duits, Engels
Over mij
I’m Hughes Helen, a regulatory writer and medical device compliance specialist with strong experience supporting FDA submissions, 510(k) documentation, and regulatory ready technical files. I help manufacturers present clear, structured, and compliant documentation that meets FDA, CE, and international regulatory expectations. My work focuses on accuracy, clarity, and full alignment with medical device standards.
If you need reliable support for regulatory documents, 510(k) preparation, risk management files, or compliance reporting, I’m here to assist.
Skills
Hughes Helen
offline •
Bekijk mijn diensten
Juridische documenten en beoordeling
I will prepare fda 510k submission, regulatory documentation, device compliance files
Juridische documenten en beoordeling
I will draft medical device technical file, risk analysis and regulatory documents
