[et_pb_section fb_built=”1″ admin_label=”Header” _builder_version=”4.16″ _module_preset=”default” use_background_color_gradient=”on” background_color_gradient_direction=”90deg” background_color_gradient_stops=”rgba(0,0,0,0) 50%|#fff6ee 50%” background_color_gradient_start=”rgba(0,0,0,0)” background_color_gradient_start_position=”50%” background_color_gradient_end=”#fff6ee” background_color_gradient_end_position=”0%” overflow-x=”hidden” global_colors_info=”{}”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_3″ _builder_version=”4.16″ _module_preset=”default” z_index=”10″ custom_padding=”|||120px|false|false” custom_padding_tablet=”|||0px|false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”68px” header_line_height=”1.2em” custom_margin=”||5px||false|false” header_font_size_tablet=”48px” header_font_size_phone=”32px” header_font_size_last_edited=”on|phone” header_line_height_tablet=”” header_line_height_phone=”1.4em” header_line_height_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_font_size=”18px” text_line_height=”1.8em” custom_margin_tablet=”|||50px|false|false” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”off|desktop” text_font_size_tablet=”16px” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” text_line_height_last_edited=”off|phone” locked=”off” global_colors_info=”{}”]”All men by nature tend to knowledge.” Aristotel[\/et_pb_text][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/medical-device-svetovanje.jpg” title_text=”medical-device-svetovanje” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-42.png” title_text=”acupuncture-42″ align=”right” _builder_version=”4.16″ _module_preset=”default” custom_margin=”|30px|||false|false” global_colors_info=”{}”][\/et_pb_image][et_pb_button button_url=”https:\/\/www.medical-device.si\/en\/contact\/” button_text=”BOOK AN APPOINTMENT” button_alignment=”center” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”16px” button_bg_color=”#063765″ button_border_color=”rgba(0,0,0,0)” button_border_radius=”0px” button_font=”|700||on|||||” button_icon=”5||divi||400″ background_layout=”dark” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”off|tablet” custom_padding=”15px|40px|15px|40px|true|true” locked=”off” global_colors_info=”{}”][\/et_pb_button][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-85.png” title_text=”acupuncture-85″ _builder_version=”4.16″ _module_preset=”default” transform_translate=”50%|50%” positioning=”absolute” position_origin_a=”bottom_right” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”About” _builder_version=”4.16″ _module_preset=”default” custom_padding=”||2px||false|false” locked=”off” global_colors_info=”{}”][et_pb_row admin_label=”Row” _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||0px|||” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ admin_label=”Column” _builder_version=”4.16″ _module_preset=”default” background_enable_image=”off” background_size=”contain” background_position=”top_left” custom_padding_tablet=”0px||30px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-23.png” _builder_version=”4.16″ _module_preset=”default” positioning=”absolute” position_origin_a=”top_right” vertical_offset=”-80px” horizontal_offset=”1px” custom_margin=”||||false|false” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.16″ _module_preset=”default” header_2_font=”|700|||||||” header_2_font_size=”35px” header_2_line_height=”1.2em” background_image=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-49.jpg” background_size=”contain” background_position=”center_left” max_width=”800px” custom_margin=”||||false|false” custom_padding=”30px||30px|50px|true|false” custom_padding_tablet=”|||30px|true|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” header_2_font_size_tablet=”30px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|tablet” header_2_line_height_tablet=”1.4em” header_2_line_height_phone=”1.5em” header_2_line_height_last_edited=”on|tablet” locked=”off” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_line_height=”1.8em” custom_margin=”||||false|false” custom_margin_tablet=”” custom_margin_phone=”” custom_margin_last_edited=”on|phone” text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” text_line_height_tablet=”” text_line_height_phone=”” text_line_height_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n
I offer services such as:<\/strong><\/p>\n I offer the service of quick searching for a suitable notified body in one-step for manufacturers of medical devices and in vitro diagnostic devices.<\/p>\n [\/et_pb_text][et_pb_button button_url=”#” url_new_window=”on” button_text=”READ MORE” button_alignment=”center” _builder_version=”4.17.4″ _module_preset=”default” custom_button=”on” button_text_size=”16px” button_bg_color=”#063765″ button_border_color=”rgba(0,0,0,0)” button_border_radius=”0px” button_letter_spacing=”2px” button_font=”|700||on|||||” button_icon=”5||divi||400″ background_layout=”dark” custom_margin=”||30px||false|false” custom_margin_tablet=”50px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”15px|40px|15px|40px|true|true” hover_enabled=”0″ locked=”off” global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_button][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_line_height=”1.8em” custom_margin=”||50px||false|false” text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” text_line_height_tablet=”” text_line_height_phone=”” text_line_height_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]I provide services for manufacturers, authorized representatives, importers, distributors, notified bodies and other institutions that operate and deal with topics in the field of medical devices.<\/p>\n I communicate with the competent authorities on your behalf. I offer you support in tailor-made training from theory to practice and I carry out internal assessments for you independently and impartially.<\/p>\n I follow all news from the field, which is constantly evolving and offers innovative solutions.<\/p>\n I advise on strategic projects related to quality and regulatory matters for medical devices.<\/p>\n Through cooperation in the network, I help you find the right distributor in the EU member states.<\/p>\n Do not hesitate to contact me to get the right solutions for your challenges.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”FAQ” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” use_background_color_gradient=”on” background_color_gradient_direction=”90deg” background_color_gradient_stops=”#f4d5b8 14%|rgba(0,0,0,0) 14%” background_color_gradient_start=”#f4d5b8″ background_color_gradient_start_position=”14%” background_color_gradient_end=”rgba(0,0,0,0)” background_color_gradient_end_position=”0%” background_enable_image=”off” background_size=”contain” background_position=”center_left” max_width=”740px” custom_padding=”0px|||40px|false|false” border_color_all=”#f4d5b8″ border_width_top=”1px” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-85.png” title_text=”acupuncture-85″ _builder_version=”4.16″ _module_preset=”default” transform_translate=”50%|-50%” transform_translate_linked=”off” positioning=”absolute” position_origin_a=”top_right” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.16″ _module_preset=”default” header_2_font=”|700|||||||” header_2_font_size=”48px” header_2_line_height=”1.2em” custom_margin=”30px||||false|false” header_2_font_size_tablet=”30px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|tablet” header_2_line_height_tablet=”1.4em” header_2_line_height_phone=”1.5em” header_2_line_height_last_edited=”on|tablet” locked=”off” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” max_width=”640px” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_line_height=”1.8em” custom_margin=”||50px||false|false” text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” text_line_height_tablet=”” text_line_height_phone=”” text_line_height_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n Do not hesitate to contact me to get the right solutions for your challenges.<\/strong><\/p>\n [\/et_pb_text][et_pb_button button_url=”https:\/\/www.medical-device.si\/en\/contact\/” button_text=”BOOK AN APPOINTMENT” button_alignment=”center” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”16px” button_bg_color=”#063765″ button_border_color=”rgba(0,0,0,0)” button_border_radius=”0px” button_font=”|700||on|||||” button_icon=”5||divi||400″ background_layout=”dark” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”off|tablet” custom_padding=”15px|40px|15px|40px|true|true” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Footer” _builder_version=”4.5.7″ _module_preset=”default” background_color=”#001b34″ global_module=”337″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”The company” use_icon=”on” font_icon=”||divi||400″ icon_color=”#e9bf96″ icon_placement=”left” image_icon_width=”16px” content_max_width=”1100px” _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”22px” header_line_height=”1.2em” body_text_color=”rgba(255,255,255,0.7)” body_line_height=”1.8em” background_layout=”dark” animation=”off” header_font_size_tablet=”20px” header_font_size_phone=”18px” header_font_size_last_edited=”on|tablet” header_line_height_tablet=”1.2em” header_line_height_phone=”” header_line_height_last_edited=”on|phone” body_font_size_tablet=”” body_font_size_phone=”14px” body_font_size_last_edited=”on|phone” icon_font_size=”16px” global_colors_info=”{}”]<\/p>\n MedDev Re\u0161itve,<\/strong> Marcia Elena Podbor\u0161ek s.p.<\/p>\n Dragomelj 78A, 1230 Dom\u017eale, Slovenia<\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Phone” use_icon=”on” font_icon=”||divi||400″ icon_color=”#e9bf96″ icon_placement=”left” image_icon_width=”16px” content_max_width=”1100px” _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”22px” header_line_height=”1.2em” body_text_color=”rgba(255,255,255,0.7)” body_line_height=”1.8em” background_layout=”dark” animation=”off” header_font_size_tablet=”20px” header_font_size_phone=”18px” header_font_size_last_edited=”on|tablet” header_line_height_tablet=”1.2em” header_line_height_phone=”” header_line_height_last_edited=”on|phone” body_font_size_tablet=”” body_font_size_phone=”14px” body_font_size_last_edited=”on|phone” icon_font_size=”16px” global_colors_info=”{}”]<\/p>\n 00386 41 556 499<\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Email” use_icon=”on” font_icon=”||divi||400″ 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I advise economic operators in the field of medical devices and adapt my services to the individual requirements and needs of clients. I offer services such as: Review and coordination in the preparation of relevant of\u00a0QMS documentation Make recommendations for improvements and regulation of areas necessary for compliance with MDR \/ IVDR advising on the implementation of the assessment by the notified I advise on the\u00a0registration of activities I advise on the\u00a0registration of a medical device I advise on the preparation of\u00a0post market surveillance (PMS)for a medical device I advise on setting up a\u00a0vigilance system Depending on your needs, I prepare and carry out internal training for you individually. I offer the service of quick searching for a suitable notified body in one-step for manufacturers of medical devices and in vitro diagnostic devices.I provide services for manufacturers, authorized representatives, importers, distributors, notified bodies and other institutions that operate and deal with topics in the field of medical devices. I communicate with the competent authorities on your behalf. I offer you support in tailor-made training from theory to practice and I carry […]<\/p>\n","protected":false},"author":1,"featured_media":280,"parent":0,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-284","page","type-page","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/pages\/284","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/comments?post=284"}],"version-history":[{"count":14,"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/pages\/284\/revisions"}],"predecessor-version":[{"id":467,"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/pages\/284\/revisions\/467"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/media\/280"}],"wp:attachment":[{"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/media?parent=284"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
Do you ask questions about the new legislation such as\u2026<\/h2>\n
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Do you know the answers?<\/h3>\n