{"id":756,"date":"2021-06-09T18:49:43","date_gmt":"2021-06-09T18:49:43","guid":{"rendered":"https:\/\/unitascertificationservices.co.uk\/home\/?page_id=756"},"modified":"2021-06-09T18:53:23","modified_gmt":"2021-06-09T18:53:23","slug":"iso-13485-certification","status":"publish","type":"page","link":"https:\/\/unitascertificationservices.co.uk\/home\/iso-13485-certification\/","title":{"rendered":"ISO 13485 Certification"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"756\" class=\"elementor elementor-756\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-82f05aa elementor-section-full_width elementor-section-height-default elementor-section-height-default jltma-glass-effect-no\" data-id=\"82f05aa\" 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-top-column elementor-element elementor-element-2772faf jltma-glass-effect-no\" data-id=\"2772faf\" 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-5e6d6e1 jltma-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"5e6d6e1\" 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\">ISO 13485 Certification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af9384d elementor-widget-divider--view-line jltma-glass-effect-no elementor-widget elementor-widget-divider\" data-id=\"af9384d\" 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<div class=\"elementor-element elementor-element-a8e1ff7 jltma-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"a8e1ff7\" 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 style=\"text-align: center;\"><span style=\"color: #ffffff;\"><a style=\"color: #ffffff;\" href=\"https:\/\/unitascertificationservices.co.uk\/home\/\">Home<\/a> \/<a title=\"ISO 9001 Certification\" href=\"https:\/\/unitascertificationservices.co.uk\/home\/iso-9001-certification-qms\/\"><span style=\"color: #ff0000;\"> <a href=\"#\"><span style=\"color: #ff0000;\">ISO 13485 Certification<\/span><\/a><\/span><\/a><\/span><\/p>\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7ee4aee elementor-section-boxed elementor-section-height-default elementor-section-height-default jltma-glass-effect-no\" data-id=\"7ee4aee\" 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-8c83958 jltma-glass-effect-no\" data-id=\"8c83958\" 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-8604d01 elementor-widget-divider--view-line jltma-glass-effect-no elementor-widget elementor-widget-divider\" data-id=\"8604d01\" 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<div class=\"elementor-element elementor-element-383118e jltma-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"383118e\" 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<h1 class=\"elementor-heading-title elementor-size-default\">ISO 13485 Certification<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a58544a elementor-widget-divider--view-line jltma-glass-effect-no elementor-widget elementor-widget-divider\" data-id=\"a58544a\" 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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e53d1b8 jltma-glass-effect-no\" data-id=\"e53d1b8\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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-ad6424a elementor-section-boxed elementor-section-height-default elementor-section-height-default jltma-glass-effect-no\" data-id=\"ad6424a\" 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-3023e4a jltma-glass-effect-no\" data-id=\"3023e4a\" 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-503fa81 jltma-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"503fa81\" 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>ISO 13485 specifies requirements for a medical device quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As result, it includes some requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization<\/p><h2 class=\"elementor-heading-title elementor-size-default\">Benefits of ISO 13485(MDQMS)<\/h2>\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-75edaca elementor-align-left elementor-icon-list--layout-traditional elementor-list-item-link-full_width jltma-glass-effect-no elementor-widget elementor-widget-icon-list\" data-id=\"75edaca\" 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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/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\">Increase access to more markets worldwide with certification.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/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\">Outline how to review and improve processes across your organization.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/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\">Increase efficiency, cut costs and monitor supply chain performance.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\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<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check-circle\"><\/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\">Demonstrate that you produce safer and more effective medical devices.<\/span>\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\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-2700248 jltma-glass-effect-no\" data-id=\"2700248\" 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-197d77f eael-wpforms-labels-yes eael-wpforms-form-button-custom jltma-glass-effect-no elementor-widget elementor-widget-eael-wpforms\" data-id=\"197d77f\" data-element_type=\"widget\" data-widget_type=\"eael-wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-contact-form eael-wpforms eael-wpforms-align-left\">\n                                <div class=\"wpforms-container wpforms-container-full\" id=\"wpforms-710\"><form id=\"wpforms-form-710\" class=\"wpforms-validate wpforms-form\" data-formid=\"710\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/home\/wp-json\/wp\/v2\/pages\/756\" data-token=\"cb5ae43202c348c0e42fdf6fdab9d9f3\" data-token-time=\"1775732836\"><div class=\"wpforms-head-container\"><div class=\"wpforms-title\">Get Certification<\/div><\/div><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div class=\"wpforms-field-container\"><div 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id=\"wpforms-710-field_6\" class=\"wpforms-field-medium wpforms-field-required choicesjs-select\" data-size-class=\"wpforms-field-row wpforms-field-medium\" data-search-enabled=\"1\" name=\"wpforms[fields][6][]\" required=\"required\" multiple=\"multiple\"><option value=\"\" class=\"placeholder\" disabled ><\/option><option value=\"G-MARK Certification\"  selected='selected' class=\"choice-20 depth-1\"  >G-MARK Certification<\/option><option value=\"ISO 9001 Certification \"  class=\"choice-1 depth-1\"  >ISO 9001 Certification<\/option><option value=\"ISO 22000 Certification \"  class=\"choice-3 depth-1\"  >ISO 22000 Certification<\/option><option value=\"ISO 14001 Certification \"  class=\"choice-2 depth-1\"  >ISO 14001 Certification<\/option><option value=\"ISO 180001 Certification \"  class=\"choice-6 depth-1\"  >ISO 180001 Certification<\/option><option value=\"ISO 27001 Certification \"  class=\"choice-7 depth-1\"  >ISO 27001 Certification<\/option><option value=\"ISO 28000 Certification \"  class=\"choice-8 depth-1\"  >ISO 28000 Certification<\/option><option value=\"ISO 50001 Certification \"  class=\"choice-9 depth-1\"  >ISO 50001 Certification<\/option><option value=\"ISO 13485 Certification \"  class=\"choice-10 depth-1\"  >ISO 13485 Certification<\/option><option value=\"ISO 45001 Certification \"  class=\"choice-11 depth-1\"  >ISO 45001 Certification<\/option><option value=\"ISO\/TS 16949 Certification \"  class=\"choice-12 depth-1\"  >ISO\/TS 16949 Certification<\/option><option value=\"PAS \/ ISO 17712 Certification \"  class=\"choice-13 depth-1\"  >PAS \/ ISO 17712 Certification<\/option><option value=\"HACCP Certification \"  class=\"choice-14 depth-1\"  >HACCP Certification<\/option><option value=\"CE MARKING\"  class=\"choice-15 depth-1\"  >CE MARKING<\/option><option value=\"HALAL Certification \"  class=\"choice-16 depth-1\"  >HALAL Certification<\/option><option value=\"GMP Certification \"  class=\"choice-17 depth-1\"  >GMP Certification<\/option><option value=\"SA 8000 Certification \"  class=\"choice-18 depth-1\"  >SA 8000 Certification<\/option><option value=\"Other\"  class=\"choice-19 depth-1\"  >Other<\/option><\/select><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"710\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/pages\/756\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-710\" class=\"wpforms-submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><\/div><\/form><\/div>  <!-- .wpforms-container -->            <\/div>\n\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ISO 13485 Certification Home \/ ISO 13485 Certification ISO 13485 Certification ISO 13485 specifies requirements for a medical device quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective [&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":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"","ocean_second_sidebar":"","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"","ocean_custom_header_template":"","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"","ocean_menu_typo_font_family":"","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"","footnotes":""},"class_list":["post-756","page","type-page","status-publish","hentry","entry"],"_links":{"self":[{"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/pages\/756","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/comments?post=756"}],"version-history":[{"count":18,"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/pages\/756\/revisions"}],"predecessor-version":[{"id":774,"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/pages\/756\/revisions\/774"}],"wp:attachment":[{"href":"https:\/\/unitascertificationservices.co.uk\/home\/wp-json\/wp\/v2\/media?parent=756"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}