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All posts written by Veronica Grigio

Veronica Grigio

Quality Specialist & Regulatory Specialist

Laureata in Bioingegneria industriale e qualificata come Lead Auditor per le norme ISO 9001 e ISO 13485, possiede una solida base di competenze nel settore dei dispositivi medici (DM) e dei dispositivi medico-diagnostici in vitro (IVD).

Dal suo ingresso in Clariscience nel 2023 come Quality Specialist, il suo ruolo si è evoluto integrando in modo sinergico gli aspetti di Quality Assurance e Regulatory Affairs. Tra le sue responsabilità primarie rientrano la pianificazione e la conduzione di audit interni e di seconda parte, la redazione e revisione della documentazione del Sistema di Gestione per la Qualità (SGQ), nonché la comprensione e l’applicazione dei requisiti regolatori specifici per DM e IVD, contribuendo attivamente alla redazione della documentazione tecnica e alle attività formative in ambito regolatorio.

Inspection verification is a fundamental tool that companies can—and must—adopt to assess whether their Quality Management System (internal audit) or…
The risk management activity should be entrusted to a qualified team formed for this purpose, usually consisting of at least…
The data recording system aims to collect the results of all activities performed, all checks conducted, and the results obtained,…
The ISO 13485 standard establishes that the organization must conduct internal audits at planned intervals: it is good practice to…
The ISO 13485 standard for Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes establishes that the documentation…
MDSAP è un programma di audit che consente la valutazione della conformità del Sistema di Gestione per la Qualità (SGQ)…

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