{"id":7000152507,"date":"2025-02-05T09:53:32","date_gmt":"2025-02-05T09:53:32","guid":{"rendered":"https:\/\/www.plastod.com\/?page_id=7000152507"},"modified":"2026-03-25T14:55:02","modified_gmt":"2026-03-25T14:55:02","slug":"certificazioni","status":"publish","type":"page","link":"https:\/\/www.plastod.com\/it\/certificazioni\/","title":{"rendered":"Certificazioni"},"content":{"rendered":"

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Conformit\u00e0 dei prodotti<\/h1>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ text_font=”Rubik|300|||||||” text_text_color=”#FFFFFF” text_font_size=”16px” text_line_height=”1.4em” custom_margin_tablet=”” custom_margin_phone=”20px||||false|false” custom_margin_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]Ci impegniamo a offrire soluzioni medicali sicure, affidabili e di alta qualit\u00e0 ai nostri clienti in Italia e nel mondo.[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.27.4″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”on|on|off” _builder_version=”4.27.4″ _module_preset=”default” background_color=”rgba(255,255,255,0.7)” positioning=”none” position_origin_a=”bottom_center” z_index=”9999″ width=”100%” max_width=”100%” custom_margin=”0px||0px||false|false” custom_padding=”5px|3%|5px|3%|false|false” custom_css_main_element=”-webkit-backdrop-filter: blur(5px);||backdrop-filter: blur(25px);” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][difl_breadcrumbs use_separator_icon=”on” separator_font_icon=”5||divi||400″ separator_icon_color=”gcid-50828945-3c18-4689-ac10-51c91885c7a7″ separator_icon_font_size=”20px” pages_background_bgcolor=”RGBA(255,255,255,0)” active_page_background_bgcolor=”RGBA(255,255,255,0)” home_text=”Home” _builder_version=”4.27.4″ _module_preset=”default” pages_font_font=”Rubik||||||||” pages_font_text_color=”gcid-50828945-3c18-4689-ac10-51c91885c7a7″ home_font_text_color=”gcid-50828945-3c18-4689-ac10-51c91885c7a7″ active_page_font_text_color=”gcid-50828945-3c18-4689-ac10-51c91885c7a7″ pages_font_font_size_tablet=”” pages_font_font_size_phone=”12px” pages_font_font_size_last_edited=”on|phone” home_font_font_size_tablet=”” home_font_font_size_phone=”12px” home_font_font_size_last_edited=”on|phone” global_colors_info=”{%22gcid-50828945-3c18-4689-ac10-51c91885c7a7%22:%91%22active_page_font_text_color%22,%22pages_font_text_color%22,%22home_font_text_color%22,%22separator_icon_color%22%93}”][\/difl_breadcrumbs][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”Feature” _builder_version=”4.27.4″ background_color=”gcid-fcb21a65-60bb-4ef6-a6ac-f8f6605cdad3″ custom_padding=”100px||80px||false|” custom_padding_tablet=”50px||50px||true|false” custom_padding_phone=”50px||50px||true|false” border_radii=”off||||” global_colors_info=”{%22gcid-fcb21a65-60bb-4ef6-a6ac-f8f6605cdad3%22:%91%22background_color%22%93}”][et_pb_row column_structure=”1_2,1_2″ use_custom_gutter=”on” gutter_width=”2″ _builder_version=”4.27.4″ _module_preset=”default” width=”95%” width_tablet=”95%” width_phone=”90%” width_last_edited=”on|phone” max_width=”1920px” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ header_font=”||||||||” header_2_font=”||||||||” header_3_font=”Rubik|300|||||||” header_3_text_color=”gcid-50828945-3c18-4689-ac10-51c91885c7a7″ header_3_font_size=”28px” header_3_line_height=”1.2em” custom_margin=”||10px|||” header_3_font_size_tablet=”24px” header_3_font_size_phone=”22px” header_3_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{%22gcid-50828945-3c18-4689-ac10-51c91885c7a7%22:%91%22header_3_text_color%22,%22header_3_text_color%22%93}”]<\/p>\n

Operando in un mercato globale dei dispositivi medici in costante evoluzione, Plastod si adatta continuamente ai nuovi sviluppi tecnologici e ai cambiamenti normativi. Garantire standard elevati di qualit\u00e0, sicurezza e responsabilit\u00e0 ambientale richiede un modello organizzativo altamente efficiente.<\/h3>\n

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Il Sistema di Gestione di Plastod copre tutte le fasi di progettazione, produzione e controllo qualit\u00e0 dei dispositivi medici. L\u2019azienda \u00e8 certificata da un organismo notificato riconosciuto a livello internazionale e accreditato a livello europeo, nel rispetto degli standard ISO 9001 <\/strong>e ISO 13485<\/strong>. Inoltre, Plastod \u00e8 soggetta ad audit da parte delle autorit\u00e0 locali, sia europee che extraeuropee, nei Paesi in cui i suoi prodotti sono registrati.<\/p>\n

La sicurezza dei prodotti<\/strong> resta una priorit\u00e0 strategica. Aggiornando costantemente le proprie competenze tecniche, conoscenze normative e applicazioni cliniche, Plastod assicura soluzioni all\u2019avanguardia in termini di qualit\u00e0 e affidabilit\u00e0.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Plastod ha completato con successo la transizione al nuovo Regolamento Europeo sui Dispositivi Medici (MDR)<\/h3>\n

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I dispositivi medici fabbricati da Plastod sono marcati CE in conformit\u00e0 alle normative vigenti sui dispositivi medici, con certificazione rilasciata dall’Organismo Notificato Kiwa Cermet Italia.<\/p>\n

Con l\u2019ottenimento della certificazione MDR con largo anticipo sulle date limite imposte dal Regolamento, Plastod si distingue come partner affidabile per supportare i clienti nell’affrontare la transizione normativa garantendo la\u00a0conformit\u00e0 ai pi\u00f9 recenti requisiti regolatori<\/strong>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Controllo sistematico dei processi<\/h3>\n

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Tutti i processi di progettazione e produzione<\/strong> di Plastod sono eseguiti con la massima attenzione e secondo elevati standard di qualit\u00e0<\/strong>. Le linee produttive e i reparti di produzione sono sottoposti a rigorosi protocolli di validazione. Le aree produttive sono classificate come camere bianche ISO 8, in grado di mantenere sotto controllo i livelli di contaminazione particellare e microbica, garantendo\u00a0la sterilit\u00e0<\/strong>\u00a0e\u00a0sicurezza<\/strong>\u00a0del prodotto.<\/p>\n

Ogni fase della produzione, inclusi i processi di sterilizzazione per irraggiamento o trattamento con ossido di etilene, \u00e8 validata e attentamente monitorata. Anche i fornitori di materie prime devono rispettare i severi standard qualitativi<\/strong> per assicurare l\u2019eccellenza del prodotto finale e la sicurezza dell\u2019utilizzatore.<\/p>\n

Plastod assicura il mantenimento della qualit\u00e0 attraverso un attento monitoraggio dei materiali e dei prodotti. Con dispositivi medici registrati a livello europeo e internazionale, l\u2019azienda opera nel pieno rispetto degli standard di conformit\u00e0, in stretta collaborazione con organismi notificati e le autorit\u00e0 regolatorie globali.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Strumenti di controllo<\/h3>\n

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Per garantire la conformit\u00e0 in ogni fase \u2014 dalla progettazione iniziale al prodotto finito \u2014 Plastod si avvale di un laboratorio interno strutturato<\/strong> in grado di effettuare test fisici e prestazionali con metodi basati su norme tenciche ed \u00e8 dotato di strumentazioni regolarmente calibrate per assicurare precisione e affidabilit\u00e0.<\/p>\n

Per test complessi<\/strong> e studi sperimentali approfonditi, Plastod collabora con laboratori esterni accreditati<\/strong>, con i quali definisce protocolli di prova e valuta i risultati.<\/p>\n

L\u2019azienda si avvale anche del supporto di consulenti esperti in applicazioni cliniche per condurre accurate analisi rischio-beneficio sui propri dispositivi medici.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Competenza su tutte le classi di rischio<\/h3>\n

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Grazie a una profonda conoscenza dei regolamenti europei e alle certificazioni ottenute, Plastod \u00e8 autorizzata a progettare e produrre dispositivi medici<\/strong> appartenenti a tutte le classi di rischio<\/strong>, dalla Classe I alla Classe III. Il criterio di classificazione dei dispositivi considera il potenziale rischio per il paziente in caso di malfunzionamento, basato principalmente sul grado di invasivit\u00e0 del dispositivo e il tempo di contatto con il corpo del paziente.<\/p>\n

Questa ampia competenza testimonia la flessibilit\u00e0 operativa dell\u2019azienda nel gestire dispositivi con diversi livelli di complessit\u00e0, garantendo sempre sicurezza, conformit\u00e0 e affidabilit\u00e0.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Le nostre certificazioni<\/h3>\n

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Plastod opera nel rispetto di certificazioni internazionalmente riconosciute, che garantiscono i pi\u00f9 elevati standard nella produzione di dispositivi medici<\/strong>:<\/p>\n

ISO 13485<\/strong> \u2013 di riferimento per i dispositivi medici, garantisce un controllo rigoroso su ogni fase del ciclo di vita del prodotto, dalla progettazione alla produzione, necessario per la sicurezza del dispositivo;<\/p>\n

ISO 9001<\/strong> \u2013 assicura un sistema di gestione della qualit\u00e0 efficace, orientato al miglioramento continuo e alla soddisfazione del cliente;<\/p>\n

Certificazione CE MDR (Regolamento UE 2017\/745)<\/strong> \u2013 la conformit\u00e0 al Regolamento Europeo garantisce requisiti rigorosi in materia di sicurezza, prestazioni e tracciabilit\u00e0<\/p>\n

Queste certificazioni testimoniano l\u2019impegno di Plastod nel fornire soluzioni medicali affidabili e di alta qualit\u00e0 a livello globale.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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Le nostre certificazioni<\/h3>\n

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Plastod opera nel rispetto di certificazioni internazionalmente riconosciute, che garantiscono i pi\u00f9 elevati standard nella produzione di dispositivi medici<\/strong>:<\/p>\n