Zainteresovana strana, Stakeholder, Zakonski proizvođač, Legal manufacturer, Ovlašćeni predstavnik, Authorised Representative, Uvoznik, Importer, Distributer, Distributor, Notifikovano telo (NB), Notified Body (NB / NoBo), Nadležni organ, Competent Authority, Osoba odgovorna za usklađenost sa propisima (PRRC), Person Responsible for Regulatory Compliance (PRRC), Ekonomski operatori, Economic operators, Organizacija za ugovorni razvoj (CDO), Contract Development Organization (CDO), Organizacija za ugovornu proizvodnju (CMO), Contract Manufacturing Organization (CMO), Deklaracija o usklađenosti, Declaration of Conformity, CE oznaka, CE marking, Ocena usklađenosti, Conformity assessment, Tehnička dokumentacija, Technical Documentation, Sistem upravljanja kvalitetom (QMS), Quality Management System (QMS), Nadzor nakon stavljanja na tržište (PMS), Post-Market Surveillance (PMS), Vigilansa / Sistem budnosti, Vigilance, Korektivna mera bezbednosti na terenu (FSCA), Field Safety Corrective Action (FSCA), Klinička evaluacija, Clinical Evaluation, Kliničko praćenje nakon stavljanja na tržište (PMCF), PMCF (Post-Market Clinical Follow-up), Designacija / Određivanje, Designation, NANDO (baza notifikovanih tela), NANDO, EUDAMED (EU baza medicinskih sredstava), EUDAMED, Swissdamed (švajcarska baza), Swissdamed, MDCG (Koordinaciona grupa za medicinska sredstva), MDCG, Treća zemlja, Third country, Sporazum o uzajamnom priznavanju (MRA), MRA (Mutual Recognition Agreement), Odgovornost / Polaganje računa, Accountability, Nepristrasnost, Impartiality, Nadzorni audit, Surveillance audit, Nenajavljeni audit, Unannounced audit, Nedostatak / Neusaglašenost, Deficiency / Non-conformity, Ponovna sertifikacija, Recertification, Kodovi designacije, Designation codes (MDA, MDN, MDS, MDT)
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22.9. 3
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