{"id":2979,"date":"2019-10-10T06:58:51","date_gmt":"2019-10-10T06:58:51","guid":{"rendered":"https:\/\/www.enprojectmedicali.com\/dev\/?page_id=2979"},"modified":"2025-04-01T10:43:28","modified_gmt":"2025-04-01T09:43:28","slug":"clinical-validation","status":"publish","type":"page","link":"https:\/\/www.enprojectmedicali.com\/en\/clinical-validation_en\/","title":{"rendered":"Certifications"},"content":{"rendered":"

[vc_row rt_row_background_width=”fullwidth” rt_row_content_width=”default” rt_row_style=”alt-style-2″ rt_column_placement=”middle” rt_row_borders=”” rt_row_shadows=”” rt_row_paddings=”true” rt_bg_effect=”classic” rt_bg_image_repeat=”repeat” rt_bg_size=”cover” rt_bg_position=”right top” rt_bg_attachment=”scroll” rt_bg_video_format=”youtube” rt_padding_top=”110″ rt_bg_image=”2359″ rt_bg_overlay_color=”rgba(42,44,47,0.66)” rt_row_height=”600″][vc_column rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll”]

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QUALITY FIRST<\/h1>\n\t\t\t\t\t<\/div>[vc_empty_space height=”22px”][\/vc_column][\/vc_row][vc_row rt_row_background_width=”fullwidth” rt_row_content_width=”default” rt_row_style=”alt-style-2″ rt_row_borders=”” rt_row_shadows=”” rt_row_paddings=”true” rt_bg_effect=”classic” rt_bg_image_repeat=”repeat” rt_bg_size=”cover” rt_bg_position=”right top” rt_bg_attachment=”scroll” rt_bg_video_format=”self-hosted” rt_padding_top=”40″ rt_padding_bottom=”100″][vc_column width=”1\/2″ rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll” rt_bg_color=”” rt_bg_overlay_color=””]
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ISO 9001:2015<\/h4>

Quality management system to conduct business processes, improve the effectiveness and efficiency regarding both product realization and service provision, obtain and enhance customer satisfaction.<\/p>\n<\/div><\/article>

Download<\/a><\/div>[\/vc_column][vc_column width=”1\/2″ rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll”]
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ISO 13485:2016<\/h4>

Standard for the quality management system specific to companies in the medical sector, it includes aspects of the ISO 9001 standard and specific requirements for the medical device sector.<\/p>\n<\/div><\/article>

Download<\/a><\/div>[\/vc_column][\/vc_row][vc_row rt_row_background_width=”fullwidth” rt_row_content_width=”default” rt_row_style=”default-style” rt_row_borders=”” rt_row_shadows=”” rt_row_paddings=”true” rt_bg_effect=”classic” rt_bg_image_repeat=”repeat” rt_bg_size=”cover” rt_bg_position=”right top” rt_bg_attachment=”scroll” rt_bg_video_format=”self-hosted” rt_padding_top=”40″ rt_padding_bottom=”100″][vc_column width=”1\/3″ rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll” rt_bg_color=”” rt_bg_overlay_color=””]
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ISO 62366 Usability Engineering<\/h4>

Process-based standard, which aims to help medical device manufacturers to design in a highly usable manner. Devices designed in compliance to this standard, guarantee extreme user-friendliness and the impossibility of performing dangerous actions <\/p>\n<\/div><\/article>[vc_column_text]<\/p>\n

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Documentation is available upon request<\/p>\n

Contact us!<\/a><\/p>\n<\/div>\n<\/div>\n

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CEI EN 60601.1.2<\/h4>

This Standard’ scope includes safety, essential performance and the electromagnetic compatibility of electromedical equipment and systems. Compliance with this standard is essential to accessing operating rooms and critical areas. Full report is available upon request<\/span><\/p>\n<\/div><\/article>

Download<\/a><\/div>[\/vc_column][vc_column width=”1\/3″ rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll”]
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CEI EN 61010.1<\/h4>

Technical standards for the safety and essential performance of electro-medical equipment. Essential to ensure the safety of operators and patients. Full report is available upon request<\/span><\/p>\n<\/div><\/article>

Download<\/a><\/div>[\/vc_column][\/vc_row][vc_row rt_row_background_width=”fullwidth” rt_row_content_width=”default” rt_row_style=”default-style” rt_row_borders=”” rt_row_shadows=”” rt_row_paddings=”true” rt_bg_effect=”classic” rt_bg_image_repeat=”repeat” rt_bg_size=”cover” rt_bg_position=”right top” rt_bg_attachment=”scroll” rt_bg_video_format=”self-hosted” rt_padding_top=”40″ rt_padding_bottom=”100″][vc_column width=”1\/2″ rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll” rt_bg_color=”” rt_bg_overlay_color=””]
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ISO 14155.1.2<\/h4>

Clinical practice for the design, execution, registration and demonstration of clinical investigations conducted on human subjects, in order to evaluate the safety or performance of medical devices for regulatory purposes. Several clinical tests and subsequent follow-ups guarantee the effectiveness of our devices<\/p>\n<\/div><\/article>

Download<\/a><\/div>[\/vc_column][vc_column width=”1\/2″ rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll”]
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Regulation 745\/2017<\/h4>

Our devices already comply with the new European regulation 745\/2017, which will obligatorily replace the old regulation 93\/42, as to ensure greater safety and effectiveness of the devices<\/p>\n<\/div><\/article>

Download<\/a><\/div>[\/vc_column][\/vc_row][vc_row rt_row_background_width=”fullwidth” rt_row_content_width=”default” rt_row_style=”alt-style-2″ rt_row_borders=”” rt_row_shadows=”” rt_row_paddings=”true” rt_bg_effect=”classic” rt_bg_image_repeat=”repeat” rt_bg_size=”cover” rt_bg_position=”right top” rt_bg_attachment=”scroll” rt_bg_video_format=”self-hosted” rt_bg_color=”#0076b2″][vc_column rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll”]
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Seal of Excellence<\/h4>

“Seal of Excellence”<\/b> is a quality mark awarded by the European Commission to excellent and positively evaluated Research and Innovation project proposals\u00a0submitted in response to the Horizon 2020 <\/b>notice. Such recognition (only 0.2% of medical companies in Europe received it) allows us to further prove the very high quality of our products<\/p>\n<\/div><\/article>

Download<\/a><\/div>[\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

[vc_row rt_row_background_width=”fullwidth” rt_row_content_width=”default” rt_row_style=”alt-style-2″ rt_column_placement=”middle” rt_row_borders=”” rt_row_shadows=”” rt_row_paddings=”true” rt_bg_effect=”classic” rt_bg_image_repeat=”repeat” rt_bg_size=”cover” rt_bg_position=”right top” rt_bg_attachment=”scroll” rt_bg_video_format=”youtube” rt_padding_top=”110″ rt_bg_image=”2359″ rt_bg_overlay_color=”rgba(42,44,47,0.66)” rt_row_height=”600″][vc_column rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll”] QUALITY FIRST [vc_empty_space height=”22px”][\/vc_column][\/vc_row][vc_row rt_row_background_width=”fullwidth” rt_row_content_width=”default” rt_row_style=”alt-style-2″ rt_row_borders=”” rt_row_shadows=”” rt_row_paddings=”true” rt_bg_effect=”classic” rt_bg_image_repeat=”repeat” rt_bg_size=”cover” rt_bg_position=”right top” rt_bg_attachment=”scroll” rt_bg_video_format=”self-hosted” rt_padding_top=”40″ rt_padding_bottom=”100″][vc_column width=”1\/2″ rt_column_shadow=”” rt_bg_image_repeat=”repeat” rt_bg_size=”auto auto” rt_bg_attachment=”scroll” rt_bg_color=”” rt_bg_overlay_color=””]ISO 9001:2015 Quality management system … Continue reading<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_titles_title":"%%sitename%% - Certificazioni e Validazioni cliniche","_seopress_titles_desc":"Tutte le certificazioni e le validazioni cliniche effettuate per supportare l'efficacia dei nostri dispositivi biomedicali.","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":0,"_seopress_social_fb_img_height":0,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"both","_seopress_redirections_param":"","_seopress_redirections_type":301,"_seopress_analysis_target_kw":"validazioni cliniche","footnotes":""},"class_list":["post-2979","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.enprojectmedicali.com\/en\/wp-json\/wp\/v2\/pages\/2979","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.enprojectmedicali.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.enprojectmedicali.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.enprojectmedicali.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.enprojectmedicali.com\/en\/wp-json\/wp\/v2\/comments?post=2979"}],"version-history":[{"count":0,"href":"https:\/\/www.enprojectmedicali.com\/en\/wp-json\/wp\/v2\/pages\/2979\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.enprojectmedicali.com\/en\/wp-json\/wp\/v2\/media?parent=2979"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}