{"id":6432,"date":"2019-09-05T16:02:05","date_gmt":"2019-09-05T16:02:05","guid":{"rendered":"http:\/\/www.clinres.si\/?page_id=6432"},"modified":"2025-11-23T16:34:04","modified_gmt":"2025-11-23T16:34:04","slug":"medical-devices-support","status":"publish","type":"page","link":"https:\/\/www.clinres.si\/en\/services\/medical-devices-support\/","title":{"rendered":"Medical Devices Support"},"content":{"rendered":"[vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; bg_image=&#8221;6473&#8243; bg_position=&#8221;center center&#8221; bg_repeat=&#8221;no-repeat&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;light&#8221; text_align=&#8221;left&#8221; top_padding=&#8221;10%&#8221; bottom_padding=&#8221;15%&#8221; color_overlay=&#8221;#000000&#8243; overlay_strength=&#8221;0.5&#8243; enable_shape_divider=&#8221;true&#8221; shape_divider_color=&#8221;#ffffff&#8221; shape_divider_position=&#8221;bottom&#8221; 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tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221; enable_animation=&#8221;true&#8221; animation=&#8221;fade-in&#8221; offset=&#8221;vc_col-lg-6 vc_col-md-6 vc_col-xs-12&#8243;][vc_column_text css_animation=&#8221;fadeInUp&#8221; css=&#8221;.vc_custom_1567699609548{margin-bottom: 15px !important;}&#8221;]\n<h5>Services<\/h5>\n[\/vc_column_text][split_line_heading]\n<h2>Medical Devices Support<\/h2>\n[\/split_line_heading][\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-6-percent&#8221; column_padding_position=&#8221;bottom&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; width=&#8221;1\/4&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; 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tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][page_submenu alignment=&#8221;center&#8221; sticky=&#8221;true&#8221;][page_link link_url=&#8221;\/en\/services\/clinical-trial-services\/&#8221; title=&#8221;Clinical Trial Services&#8221; id=&#8221;1763915624764-4&#8243; tab_id=&#8221;1763915624765-4&#8243;][vc_column_text][\/vc_column_text][\/page_link][page_link link_url=&#8221;\/en\/services\/regulatory-affairs-services\/&#8221; title=&#8221;Regulatory Affairs Services&#8221; id=&#8221;1763915624805-2&#8243; tab_id=&#8221;1763915624806-4&#8243;][vc_column_text][\/vc_column_text][\/page_link][page_link title=&#8221;Pharmacovigilance&#8221; id=&#8221;1763915624825-8&#8243; link_url=&#8221;\/en\/services\/pharmacovigilance\/&#8221; tab_id=&#8221;1763915624826-3&#8243;][\/page_link][page_link title=&#8221;Quality assurance&#8221; id=&#8221;1763915624866-0&#8243; link_url=&#8221;\/en\/services\/quality-assurance\/&#8221; tab_id=&#8221;1763915624866-9&#8243;][\/page_link][page_link title=&#8221;Medical Devices Support&#8221; id=&#8221;1763915624881-1&#8243; link_url=&#8221;\/en\/services\/medical-devices-support\/&#8221; tab_id=&#8221;1763915624881-5&#8243;][\/page_link][page_link title=&#8221;Other services&#8221; id=&#8221;1763915624897-6&#8243; link_url=&#8221;\/en\/services\/other-services\/&#8221; tab_id=&#8221;1763915624898-7&#8243;][\/page_link][page_link title=&#8221;GMP\/GDP Services&#8221; id=&#8221;1763915628718-9&#8243; tab_id=&#8221;1763915628721-5&#8243; link_url=&#8221;https:\/\/www.clinres.si\/en\/services\/gmp-and-gdp-services\/&#8221;][\/page_link][\/page_submenu][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; top_padding=&#8221;7%&#8221; bottom_padding=&#8221;7%&#8221; overlay_strength=&#8221;0.3&#8243; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221;][vc_column column_padding=&#8221;padding-2-percent&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_link_target=&#8221;_self&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]\n<h2>Medical Devices Support<\/h2>\n[\/vc_column_text][\/vc_column][vc_column column_padding=&#8221;padding-2-percent&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_link_target=&#8221;_self&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]Clinres Farmacija offers a wide range of services in the field of medical devices. Given the diversity of this area, our service packages are tailored to meet the various needs and requirements of companies.<\/p>\n<p>Our services include:<\/p>\n<ul>\n<li><strong>Regulatory compliance<\/strong>: We assist in ensuring compliance with all relevant regulations and standards at the national level (e.g. compliance with MDR ((EU) 2017\/745), IVDR ((EU) 2017\/746), and ISO 13485 for quality management systems).<\/li>\n<li><strong>Translation preparation<\/strong>: We provide professional translations of instructions for use, labelling, and other important documents in accordance with legal requirements.<\/li>\n<li><strong>Packaging review<\/strong>: We carefully review the packaging and labelling of medical devices to ensure compliance with regulatory requirements regarding the necessary labels and information.<\/li>\n<li><strong>Promotional material review<\/strong>: We ensure that promotional materials comply with all legal and regulatory guidelines.<\/li>\n<li><strong>Registration<\/strong>: We provide assistance with the registration of medical devices and the registration of business activities with the competent authority.<\/li>\n<li><strong>Consulting<\/strong>: We offer expert consulting in the field of medical device regulation, including interpretation of regulations, market entry strategies, and solving regulatory issues.<\/li>\n<li><strong>Collaboration with regulatory authorities<\/strong>: We assist with communication and collaboration with regulatory bodies and ensure compliance with their requirements.<\/li>\n<li><strong>Vigilance<\/strong>: We provide support in meeting the requirements for reporting adverse events and complications to ensure post-market safety of the devices.<\/li>\n<li><strong>Operational procedures<\/strong>: We assist in preparing operational procedures related to company activities, processes, and workflows.<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"<p>[vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; bg_image=&#8221;6473&#8243; bg_position=&#8221;center center&#8221; bg_repeat=&#8221;no-repeat&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;light&#8221; text_align=&#8221;left&#8221; top_padding=&#8221;10%&#8221; bottom_padding=&#8221;15%&#8221; color_overlay=&#8221;#000000&#8243; overlay_strength=&#8221;0.5&#8243; enable_shape_divider=&#8221;true&#8221; shape_divider_color=&#8221;#ffffff&#8221; shape_divider_position=&#8221;bottom&#8221; shape_divider_height=&#8221;100&#8243; bg_image_animation=&#8221;none&#8221; parallax_bg=&#8221;true&#8221; parallax_bg_speed=&#8221;fast&#8221; shape_type=&#8221;mountains&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221;&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":6396,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false},"_links":{"self":[{"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/pages\/6432"}],"collection":[{"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/comments?post=6432"}],"version-history":[{"count":11,"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/pages\/6432\/revisions"}],"predecessor-version":[{"id":6854,"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/pages\/6432\/revisions\/6854"}],"up":[{"embeddable":true,"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/pages\/6396"}],"wp:attachment":[{"href":"https:\/\/www.clinres.si\/en\/wp-json\/wp\/v2\/media?parent=6432"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}