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Sandra M.
@gmhra_reg
MHRA FDA Registration and UKCA Medical Device Compliance
United Kingdom
English, Spanish, German, Italian
About me
I help medical device manufacturers, importers, distributors, and healthcare businesses navigate UK and US regulatory requirements. I specialize in MHRA registration, FDA medical device registration, UKCA compliance, FDA compliance, and medical device regulatory affairs. My services also cover EU MDR documentation, CE marking, ISO 13485 documentation, technical files, device listing, and regulatory compliance support. I focus on accurate documentation, practical guidance, and helping businesses prepare for regulatory requirements with confidence. Contact me to discuss your project.
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Sandra M.
Offline •
Average response time: 1 hour
See my services
Medical Device Regulatory
I will handle mhra fda ukca medical device compliance
