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MD & IVD Consultant è una realtà specializzata nella consulenza regolatoria e qualità per dispositivi medici (MD) e diagnostici in vitro (IVD). Supportiamo aziende, startup e organizzazioni lungo l’intero ciclo di vita del prodotto, dalla definizione della strategia regolatoria alla preparazione della documentazione tecnica, fino all’implementazione e al mantenimento di Sistemi di Gestione Qualità conformi agli standard internazionali. Operiamo sia in ambito europeo sia nei principali mercati extra-UE, offrendo supporto per registrazioni internazionali, attività di audit, PMS e gestione della vigilanza. Il nostro approccio è pragmatico e orientato al risultato: lavoriamo a stretto contatto con i clienti per costruire soluzioni sostenibili, efficaci e allineate alle aspettative degli Organismi Notificati e delle Autorità Competenti.
Via Irma Bandiera, 18, 40134, Bologna, Italy
Elisa and Luca were fantastic throughout the whole audit (ISO 9001, ISO 13485) process - from helping us get prepared to being right there with us on the day. They made everything so much smoother than we expected, and it was genuinely a pleasure working with them. We'd recommend them to anyone without hesitation!
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