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Claudia Mesica
@mesica_fda
ISO Management Systems Consultant
Großbritannien
Englisch
Über mich
Hi, I’m Claudia, a certified Regulatory & Compliance Specialist with 500+ successful projects and 300+ client recommendations worldwide. I specialize in ISO 9001, 13485, 27001, 14001 & 37001 documentation, QMS/ISMS manuals, policies, procedures, US FDA registration, US Agent services, device listing, 510(k) support, EU MDR/CE & medical device compliance. I deliver accurate, audit-ready documentation, practical guidance, responsive communication, and dependable regulatory support tailored to your requirements.
Kompetenzen
Claudia Mesica
offline •
Durchschnittliche Antwortzeit: 2 Stunden
Meine Dienstleistungen
Gewerbeanmeldung
I will provide eu mdr ce and iso 13485 mediacal device certification
Gewerbeanmeldung
I will do fda registration, US agent, otc listing,and product label design, fsvp, npn
Portfolio
Arbeitserfahrung
ISO Management Systems Consultant
Isodirect • Freiberufler
Apr 2026 - Present • 4 mos
ISO Management Systems Consultant specializing in the development of management system documentation, manuals, procedures, policies, and compliance frameworks for organizations and professional clients. Worked with UESE ITALIA S.p.A. on the development of an ISO 9001:2015 Quality Management System, including a tailored Quality Management Manual, process documentation, quality objectives, document control structure, responsibilities, and procedures aligned with the organization's consulting and service operations. Developed structured information requirements and checklists to streamline the collection of client data for ISO documentation projects. Supported the development of reusable documentation frameworks for ISO 9001, ISO 14001, ISO 13485, ISO 27001, and ISO 45001, with additional expertise in ISO 50001 management system documentation. Areas of expertise include ISO management system documentation, QMS, ISMS, policies and procedures, compliance documentation, internal audit support, process mapping, risk-based thinking, documented information, continual improvement, and management system implementation support.
ISO Documentation & QMS Consultant
Independent Compliance Documentation Practice • Freiberufler
Jun 2025 - Present • 1 yr 2 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.
