{"id":1038,"date":"2021-11-05T13:48:11","date_gmt":"2021-11-05T12:48:11","guid":{"rendered":"https:\/\/cmo.biofaktor.site\/safety\/"},"modified":"2025-09-15T10:12:11","modified_gmt":"2025-09-15T08:12:11","slug":"safety","status":"publish","type":"page","link":"https:\/\/cmo.biofaktor.pl\/en\/safety\/","title":{"rendered":"Safety"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1038\" class=\"elementor elementor-1038 elementor-651\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5f7cc5c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5f7cc5c\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1c3feef\" data-id=\"1c3feef\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-55a7422 elementor-widget elementor-widget-heading\" data-id=\"55a7422\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Safety<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-616c225 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"616c225\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2daf9c2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2daf9c2\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-f17a710\" data-id=\"f17a710\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-364765d elementor-widget elementor-widget-image\" data-id=\"364765d\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"763\" src=\"https:\/\/cmo.biofaktor.pl\/wp-content\/uploads\/2021\/11\/CMO-bezpieczenstwo-1024x976.webp\" class=\"attachment-large size-large wp-image-1682\" alt=\"\" srcset=\"https:\/\/cmo.biofaktor.pl\/wp-content\/uploads\/2021\/11\/CMO-bezpieczenstwo-1024x976.webp 1024w, https:\/\/cmo.biofaktor.pl\/wp-content\/uploads\/2021\/11\/CMO-bezpieczenstwo-300x286.webp 300w, https:\/\/cmo.biofaktor.pl\/wp-content\/uploads\/2021\/11\/CMO-bezpieczenstwo-768x732.webp 768w, https:\/\/cmo.biofaktor.pl\/wp-content\/uploads\/2021\/11\/CMO-bezpieczenstwo-1536x1463.webp 1536w, https:\/\/cmo.biofaktor.pl\/wp-content\/uploads\/2021\/11\/CMO-bezpieczenstwo-2048x1951.webp 2048w, https:\/\/cmo.biofaktor.pl\/wp-content\/uploads\/2021\/11\/CMO-bezpieczenstwo-540x514.webp 540w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-0a74659\" data-id=\"0a74659\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e57933b elementor-widget elementor-widget-heading\" data-id=\"e57933b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Reporting Medical Incidents<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a065d2 elementor-widget elementor-widget-text-editor\" data-id=\"7a065d2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>To ensure the safety of users of our medical devices and as part of our post-market safety surveillance, we collect information regarding incidents and serious medical incidents related to Biofaktor Sp. z o.o. medical devices.<\/p><p>If such an incident occurs or is suspected, please report it immediately to our Safety Monitoring Department.<\/p><p><strong>Information on Personal Data Protection<\/strong><\/p><p style=\"font-size: 14px\">Reports can also be submitted to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.<\/p><p style=\"font-size: 14px\">By submitting a medical incident report, you consent to the processing of your personal data to the extent necessary to receive, register, and analyze the report, in accordance with Regulation (EU) 2016\/679 of the European Parliament and of the Council of 27 April 2016 (GDPR).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-3193391 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3193391\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-c5d77e5\" data-id=\"c5d77e5\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-178f9f5 elementor-widget elementor-widget-heading\" data-id=\"178f9f5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">By mail<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-630273a elementor-widget elementor-widget-text-editor\" data-id=\"630273a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Biofaktor Sp. z o.o. <br \/>al. KEN 55\/28 KEN 55\/28, <br \/>02-797 Warszawa, Poland<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5fe609f elementor-widget elementor-widget-heading\" data-id=\"5fe609f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">By e-mail<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62826f4 elementor-mobile-align-left elementor-align-left elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"62826f4\" data-element_type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"mailto:incydenty.medyczne@biofaktor.pl\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-envelope\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">incydenty.medyczne@biofaktor.pl<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-712d84c elementor-widget elementor-widget-button\" data-id=\"712d84c\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/wp-content\/uploads\/2025\/09\/Formularz_zgloszenia_powaznego_incydentu_ZIM-2.doc\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">download the form<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Safety Reporting Medical Incidents To ensure the safety of users of our medical devices and as part of our post-market safety surveillance, we collect information regarding incidents and serious medical incidents related to Biofaktor Sp. z o.o. medical devices. If such an incident occurs or is suspected, please report it immediately to our Safety Monitoring [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1038","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Safety - CMO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cmo.biofaktor.pl\/en\/safety\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Safety - CMO\" \/>\n<meta property=\"og:description\" content=\"Safety Reporting Medical Incidents To ensure the safety of users of our medical devices and as part of our post-market safety surveillance, we collect information regarding incidents and serious medical incidents related to Biofaktor Sp. z o.o. medical devices. 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