[et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”Header” _builder_version=”4.16″ _module_preset=”default” background_color=”#063765″ background_image=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/medical-device-resolved-medicinski-pripomocki-1-scaled.jpg” background_position=”top_center” background_blend=”multiply” custom_margin=”||||false|false” custom_padding=”80px||0px||false|false” custom_padding_tablet=”20px||0px||false|false” custom_padding_phone=”8vw||25vw||false|false” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_4,1_4″ use_custom_gutter=”on” gutter_width=”1″ make_equal=”on” _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_css_main_element=”overflow: visible !important” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”|40px|220px||false|false” custom_padding_tablet=”|0px|40px||false|false” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” border_color_all=”rgba(255,255,255,0.2)” border_width_left=”1px” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-78.png” _builder_version=”4.16″ _module_preset=”default” custom_margin=”-18px||-140px|-47px|false|false” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”68px” header_line_height=”1.2em” background_layout=”dark” 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” 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” background_layout=”dark” custom_margin=”30px||30px||false|false” text_font_size_tablet=”16px” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” text_line_height_last_edited=”off|phone” global_colors_info=”{}”]Professional regulatory consultancy
\nto meet the obligations of the requirements of the MDR and IVDR regulations[\/et_pb_text][et_pb_button button_url=”https:\/\/www.medical-device.si\/en\/contact\/” button_text=”BOOK AN APPOINTMENT” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”16px” button_text_color=”#2a2a2a” button_bg_color=”#ffffff” 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″ custom_padding=”15px|40px|15px|40px|true|true” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ _module_preset=”default” transform_scale_tablet=”” transform_scale_phone=”” transform_scale_last_edited=”on|tablet” transform_translate=”0px|-106px” transform_translate_tablet=”0px|0px” transform_translate_phone=”” transform_translate_last_edited=”on|tablet” transform_translate_linked=”off” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|tablet” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|tablet” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|tablet” transform_styles_last_edited=”on|tablet” custom_padding=”|10px||10px|false|true” transform_styles_tablet=”” transform_styles_phone=”” border_color_all=”#eabf96″ border_width_right=”1px” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/medicinski-pripomocki-400-726-medical-device.jpg” _builder_version=”4.16″ _module_preset=”default” z_index=”1″ custom_margin=”|-10px||-10px|false|true” custom_margin_tablet=”0vw||||false|false” custom_margin_last_edited=”off|desktop” global_colors_info=”{}”][\/et_pb_image][et_pb_button button_url=”https:\/\/www.medical-device.si\/en\/consulting\/” button_text=”CONSULTING” button_alignment=”right” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”16px” button_bg_color=”rgba(0,0,0,0)” button_border_color=”rgba(0,0,0,0)” button_border_radius=”0px” button_letter_spacing=”2px” button_font=”|700||on|||||” button_icon=”$||divi||400″ button_icon_color=”#eabf96″ button_on_hover=”off” background_layout=”dark” locked=”off” global_colors_info=”{}” custom_padding__hover_enabled=”off|desktop”][\/et_pb_button][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-82-1.png” _builder_version=”4.16″ _module_preset=”default” custom_margin=”-41px||80px|-35px|false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”||0px||false|false” custom_margin_last_edited=”on|phone” global_colors_info=”{}”][\/et_pb_image][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-81.png” disabled_on=”on|off|off” _builder_version=”4.16″ _module_preset=”default” transform_translate=”50%|50%” transform_translate_linked=”off” positioning=”absolute” position_origin_a=”bottom_right” global_colors_info=”{}” width__hover_enabled=”off|desktop”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ _module_preset=”default” transform_scale_tablet=”” transform_scale_phone=”” transform_scale_last_edited=”on|tablet” transform_translate=”0px|-106px” transform_translate_tablet=”0px|0px” transform_translate_phone=”” transform_translate_last_edited=”on|tablet” transform_translate_linked=”off” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|tablet” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|tablet” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|tablet” transform_styles_last_edited=”on|tablet” custom_padding=”|||20px|false|false” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-80.png” _builder_version=”4.16″ _module_preset=”default” custom_margin=”|-10vw||-22px|false|false” custom_margin_tablet=”|0vw|||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|tablet” global_colors_info=”{}”][\/et_pb_image][et_pb_text admin_label=”Text” _builder_version=”4.16″ _module_preset=”default” text_font=”||||||||” text_text_color=”#ffe0c2″ text_font_size=”17px” text_line_height=”1.8em” background_layout=”dark” custom_margin=”260px||||false|false” custom_margin_tablet=”” custom_margin_phone=”30px||||false|false” custom_margin_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]”All men by nature tend to knowledge.”Aristotel[\/et_pb_text][\/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” global_colors_info=”{}”][et_pb_row admin_label=”Row” _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ admin_label=”Column” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider show_divider=”off” _builder_version=”4.16″ _module_preset=”default” background_color=”#f4d5b8″ positioning=”absolute” position_origin_a=”bottom_left” vertical_offset=”-60px” width=”260px” height=”400px” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.16″ _module_preset=”default” header_font_size=”29px” header_2_font=”|600|||||||” header_2_font_size=”40px” header_2_line_height=”1.2em” max_width=”720px” 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” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”90px||||false|false” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-08.png” _builder_version=”4.16″ _module_preset=”default” custom_margin=”|||-20vw|false|false” custom_margin_tablet=”-120px||||false|false” custom_margin_last_edited=”off|desktop” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_line_height=”2em” global_colors_info=”{}”]Let us work together and find appropriate solutions to the challenges you face in implementing new legislation in the field of medical devices.
\nFinding the right consultant is challenging.
\nI work on the principle of getting to know your field of activity and the current situation better, which is the basis for helping and guiding you with my knowledge and experience in finding right solutions for you. In addition, I regularly monitor innovations in the field (MDR \/ IVDR), inform you, and warn you of their impact on your business.
\nThe new legislative framework (MDR \/ IVDR) changes the obligations of economic operators operating in the field of medical devices, so it is necessary to identify critical points in the production and distribution process in order to comply with all legislative requirements. The daily challenges and questions of what an economic operator has to follow do not run out, especially if we are aware that the field of medical devices is one of the fastest growing sectors, especially, the field of new technologies and innovations.<\/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.[\/et_pb_text][et_pb_button button_url=”https:\/\/www.medical-device.si\/en\/shop\/” url_new_window=”on” button_text=”READ MORE” button_alignment=”right” _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=”||||true|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”||||false|false” custom_margin_last_edited=”on|phone” 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=”Services” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”2_5,3_5″ use_custom_gutter=”on” gutter_width=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”140px||||false|false” custom_padding_tablet=”0px||||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-20.png” _builder_version=”4.16″ _module_preset=”default” positioning=”absolute” position_origin_a=”bottom_left” vertical_offset=”70px” vertical_offset_last_edited=”off|phone” global_colors_info=”{}”][\/et_pb_image][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/Medicinski-pripomocki-Marcia-Elena-Podborsek-800-800.jpg” title_text=”Medicinski-pripomocki—Marcia-Elena-Podborsek-800-800″ _builder_version=”4.16″ _module_preset=”default” locked=”off” global_colors_info=”{}”][\/et_pb_image][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-07.png” _builder_version=”4.16″ _module_preset=”default” transform_translate=”0px|-50%” transform_translate_linked=”off” z_index=”2″ width=”100%” custom_margin_tablet=”-330px||||false|false” custom_margin_last_edited=”off|desktop” locked=”off” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”30px|||140px|false|false” custom_padding_tablet=”|||0px|false|false” custom_padding_phone=”|||0px|false|false” custom_padding_last_edited=”on|phone” border_color_all=”#063765″ border_width_top=”1px” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-84-1.png” _builder_version=”4.16″ _module_preset=”default” transform_translate=”50%|-50%” transform_translate_linked=”off” positioning=”absolute” position_origin_a=”top_right” vertical_offset_tablet=”-74px” vertical_offset_phone=”-60px” vertical_offset_last_edited=”off|desktop” horizontal_offset_tablet=”0px” horizontal_offset_phone=”0px” horizontal_offset_last_edited=”off|desktop” global_colors_info=”{}”][\/et_pb_image][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-09.jpg” title_text=”acupuncture-09″ _builder_version=”4.16″ _module_preset=”default” positioning=”absolute” horizontal_offset_tablet=”-30px” horizontal_offset_last_edited=”off|desktop” 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” max_width=”620px” custom_margin=”|||-80px|false|false” custom_margin_tablet=”|||0px|false|false” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”on|phone” 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|desktop” locked=”off” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_blurb title=”The main changes introduced by the new legislative framework of regulations compared to the directives are:” icon_placement=”left” content_max_width=”1100px” _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”22px” header_line_height=”1.2em” body_line_height=”1.8em” custom_margin=”||30px||false|false” animation=”off” header_font_size_tablet=”20px” header_font_size_phone=”18px” header_font_size_last_edited=”on|tablet” header_line_height_tablet=”1.4em” header_line_height_phone=”1.5em” header_line_height_last_edited=”on|phone” body_font_size_tablet=”” body_font_size_phone=”14px” body_font_size_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n
[\/et_pb_blurb][et_pb_button button_url=”https:\/\/www.medical-device.si\/en\/contact\/” button_text=”BOOK AN APPOINTMENT” button_alignment=”right” _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_letter_spacing=”2px” button_font=”|700||on|||||” button_icon=”5||divi||400″ background_layout=”dark” custom_margin=”30px||50px||false|false” custom_margin_tablet=”50px||||false|false” custom_margin_phone=”80px||||false|false” custom_margin_last_edited=”on|phone” 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-81.png” align=”center” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” 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” global_colors_info=”{}”]<\/p>\n
The European Commission’s goal in adopting the MDR \/ IVDR is a new legislative framework that provides safe and effective medical devices and IVD medical devices for the entire population of the European Union on the market.<\/p>\n
The free movement of goods in the field of medical devices shall apply in the territory of the European Union.<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”||0px||false|false” custom_padding=”||0px||false|false” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”MDR” url=”http:\/\/PREBERI%20VE\u010c” url_new_window=”on” use_icon=”on” font_icon=”i||divi||400″ icon_placement=”left” content_max_width=”1100px” _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”22px” header_line_height=”1.2em” body_line_height=”1.8em” custom_margin=”||30px||false|false” animation=”off” link_option_url=”https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/slv” header_font_size_tablet=”20px” header_font_size_phone=”18px” header_font_size_last_edited=”on|tablet” header_line_height_tablet=”1.4em” header_line_height_phone=”1.5em” header_line_height_last_edited=”on|phone” body_font_size_tablet=”” body_font_size_phone=”14px” body_font_size_last_edited=”on|phone” global_colors_info=”{}”][\/et_pb_blurb][et_pb_button button_url=”https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/slv” url_new_window=”on” button_text=”READ MORE” 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_letter_spacing=”2px” button_font=”|700||on|||||” button_icon=”5||divi||400″ background_layout=”dark” custom_margin=”2px||50px||false|false” custom_margin_tablet=”50px||||false|false” custom_margin_phone=”80px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”15px|40px|15px|40px|true|true” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”IVDR” url_new_window=”on” use_icon=”on” font_icon=”i||divi||400″ icon_placement=”left” content_max_width=”1100px” _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”22px” header_line_height=”1.2em” body_line_height=”1.8em” custom_margin=”||30px||false|false” animation=”off” header_font_size_tablet=”20px” header_font_size_phone=”18px” header_font_size_last_edited=”on|tablet” header_line_height_tablet=”1.4em” header_line_height_phone=”1.5em” header_line_height_last_edited=”on|phone” body_font_size_tablet=”” body_font_size_phone=”14px” body_font_size_last_edited=”on|phone” global_colors_info=”{}”][\/et_pb_blurb][et_pb_button button_url=”https:\/\/eur-lex.europa.eu\/legal-content\/SL\/TXT\/PDF\/?uri=CELEX:02017R0746-20170505&from=EN” url_new_window=”on” button_text=”READ MORE” 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_letter_spacing=”2px” button_font=”|700||on|||||” button_icon=”5||divi||400″ background_layout=”dark” custom_margin=”2px||50px||false|false” custom_margin_tablet=”50px||||false|false” custom_margin_phone=”80px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”15px|40px|15px|40px|true|true” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Useful links” url=”http:\/\/PREBERI%20VE\u010c” url_new_window=”on” use_icon=”on” font_icon=”||divi||400″ icon_placement=”left” content_max_width=”1100px” _builder_version=”4.16″ _module_preset=”default” header_font=”|700|||||||” header_font_size=”22px” header_line_height=”1.2em” body_line_height=”1.8em” custom_margin=”||30px||false|false” animation=”off” link_option_url=”https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/slv” header_font_size_tablet=”20px” header_font_size_phone=”18px” header_font_size_last_edited=”on|tablet” header_line_height_tablet=”1.4em” header_line_height_phone=”1.5em” header_line_height_last_edited=”on|phone” body_font_size_tablet=”” body_font_size_phone=”14px” body_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”][\/et_pb_blurb][et_pb_text _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
\u2022 European Commission<\/a><\/strong> [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Call to Action” _builder_version=”4.16″ _module_preset=”default” background_color=”#fff6ee” custom_padding=”0px||0px||true|false” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ use_custom_gutter=”on” gutter_width=”1″ make_equal=”on” _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px||0px||true|false” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” use_background_color_gradient=”on” background_color_gradient_stops=”#f4d5b8 0%|rgba(244,213,184,0) 100%” background_color_gradient_start=”#f4d5b8″ background_color_gradient_end=”rgba(244,213,184,0)” background_enable_image=”off” background_size=”contain” background_position=”top_right” custom_padding=”180px|80px|||false|false” custom_padding_tablet=”100px||||false|false” custom_padding_phone=”80px|0px|||false|false” custom_padding_last_edited=”on|phone” box_shadow_style=”preset7″ box_shadow_horizontal=”120px” box_shadow_vertical=”0px” box_shadow_color=”#fff6ee” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” header_2_font=”|700|||||||” header_2_font_size=”100px” header_2_font_size_tablet=”60px” header_2_font_size_phone=”32px” header_2_font_size_last_edited=”on|phone” header_2_line_height_phone=”1.2em” header_2_line_height_last_edited=”off|desktop” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_font=”||on||||||” text_text_color=”#063765″ text_font_size=”28px” text_line_height=”1.4em” text_font_size_tablet=”22px” text_font_size_phone=”18px” text_font_size_last_edited=”on|desktop” text_line_height_tablet=”” text_line_height_phone=”1.5em” text_line_height_last_edited=”on|phone” global_colors_info=”{}”]I provide you professional regulatory advice in the field of medical devices. 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″ 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=”{}”]info@medical-device.si[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Medicaldevices Resolve your challengesProfessional regulatory consultancy to meet the obligations of the requirements of the MDR and IVDR regulations”All men by nature tend to knowledge.”AristotelProfessional regulatory consultancy Meet the obligations of the requirements of the MDR and IVDR regulations Let us work together and find appropriate solutions to the challenges you face in implementing new legislation in the field of medical devices. Finding the right consultant is challenging. I work on the principle of getting to know your field of activity and the current situation better, which is the basis for helping and guiding you with my knowledge and experience in finding right solutions for you. In addition, I regularly monitor innovations in the field (MDR \/ IVDR), inform you, and warn you of their impact on your business. The new legislative framework (MDR \/ IVDR) changes the obligations of economic operators operating in the field of medical devices, so it is necessary to identify critical points in the production and distribution process in order to comply with all legislative requirements. The daily challenges and questions of what an economic operator has to follow do not run out, especially if we are aware that the field of medical devices is […]<\/p>\n","protected":false},"author":1,"featured_media":280,"parent":0,"menu_order":1,"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-279","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\/279","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=279"}],"version-history":[{"count":20,"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/pages\/279\/revisions"}],"predecessor-version":[{"id":522,"href":"https:\/\/www.medical-device.si\/en\/wp-json\/wp\/v2\/pages\/279\/revisions\/522"}],"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=279"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\u2022 EUDAMED<\/a><\/strong>
\u2022 MDCG<\/a><\/strong>
\u2022 NANDO BASE<\/a><\/strong><\/p>\n<\/h2>\n
\nI advise economic operators in the field of medical devices and adapt my services to the individual requirements and needs of clients.[\/et_pb_text][et_pb_button button_url=”https:\/\/www.medical-device.si\/en\/counseling\/” button_text=”READ MORE” button_alignment=”right” _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_letter_spacing=”2px” button_font=”|700||on|||||” button_icon=”5||divi||400″ background_layout=”dark” custom_margin=”40px||||false|false” custom_margin_tablet=”50px||||false|false” custom_margin_phone=”80px||||false|false” custom_margin_last_edited=”off|desktop” custom_padding=”15px|40px|15px|40px|true|true” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”100px||||false|false” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/acupuncture-01.png” title_text=”medical-decise-resolver-svetovanje” show_bottom_space=”off” _builder_version=”4.16″ _module_preset=”default” background_image=”https:\/\/www.medical-device.si\/wp-content\/uploads\/2021\/04\/medical-decise-resolver-svetovanje.jpg” global_colors_info=”{}”][\/et_pb_image][\/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=”4.24.2″ _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” hover_enabled=”0″ 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=”{}” sticky_enabled=”0″]MedDev Re\u0161itve,<\/strong>\u00a0Marcia Elena Podbor\u0161ek s.p.<\/span>
\nGlavni trg 18a
\n1234 Menge\u0161[\/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