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Claudia Mesica
@mesica_fda
FDA specialist for US FDA registration
Großbritannien
Englisch
Über mich
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.
Kompetenzen
Claudia Mesica
offline •
Durchschnittliche Antwortzeit: 3 Stunden
Meine Dienstleistungen
Produktsicherheit und Qualitätszertifizierung
I will do iso certification documentation and qms manuals 9001,13485,27001,14001,37001
Gewerbeanmeldung
I will provide eu mdr ce and iso 13485 mediacal device certification
Portfolio
Arbeitserfahrung
ISO Documentation & QMS Consultant
Independent Compliance Documentation Practice • Freiberufler
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.
