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mesica_fda

Claudia Mesica

@mesica_fda

FDA specialist for US FDA registration

United Kingdom
English
About me
Hi, I’m Claudia, a certified regulatory & compliance specialist with 500+ successful projects delivered and 300+ client recommendations worldwide. I provide ISO certification documentation & QMS manuals (ISO 9001, 13485, 27001, 14001, 37001), US FDA registration, US Agent services, device listing, 510(k) support, and EU MDR CE & ISO 13485 medical device certification. I deliver audit-ready, regulator-approved documentation with speed, accuracy, and zero stress. Choose me for proven expertise, fast delivery, and clear guidance. Message me now to get compliant and approved fast.... Read more

Skills

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mesica_fda
Claudia Mesica
Offline • 
Average response time: 3 hours

See my services

Product Safety & Quality Certification
I will do iso certification documentation and qms manuals 9001,13485,27001,14001,37001
From$20 / projectMore details
Business Registration
I will provide eu mdr ce and iso 13485 mediacal device certification
From$20 / projectMore details

Portfolio

Work experience

ISO Documentation & QMS Consultant

Independent Compliance Documentation Practice • Freelance

Jun 2025 - Present • 11 mos

Develop and review certification-ready documentation for businesses seeking ISO compliance and audit preparation. Focus areas include ISO 9001, ISO 13485, ISO 27001, ISO 14001, and ISO 37001 documentation, including quality manuals, SOPs, procedures, policies, records, risk-based documentation, and internal audit support materials. Help clients create structured, practical, and professional QMS documentation aligned with certification expectations while maintaining usability for real business operations.