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When a medical device is manufactured, its intended use, components, functions, and potential risks must be specified. NewMed Consulting<\/strong> also supports you<\/strong> in this process, helping you draft the technical product documentation in accordance with Annexes II and III of Regulation (EU) 2017\/745<\/strong> (MDR).<\/p>\n The drafting of these documents must be supported by adequate planning<\/strong>, for which an in-depth knowledge of the subject and the regulations required is necessary. Our company has specialized in the drafting of these documents <\/strong>and is ready to support you throughout the entire process that follows your medical device production.<\/p>\n To learn more about the technical documents that are essential for your business, contact us<\/strong> today!<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ _builder_version=”4.27.4″ _module_preset=”default” width=”90%” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”||||||||” text_text_color=”#FFFFFF” text_font_size=”15px” text_line_height=”1.8em” use_background_color_gradient=”on” background_color_gradient_direction=”200deg” background_color_gradient_stops=”gcid-6bc66947-4928-4064-aa5f-8b610795df9b 0%|#001f60 100%” width=”100%” max_width=”100%” max_width_tablet=”100%” max_width_phone=”100%” max_width_last_edited=”on|phone” custom_margin=”1px||22px||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”10px|20px|10px|20px|false|false” link_option_url=”https:\/\/health.ec.europa.eu\/medical-devices-sector_en” link_option_url_new_window=”on” hover_enabled=”0″ box_shadow_style=”preset2″ box_shadow_color=”rgba(0,0,0,0.16)” saved_tabs=”all” global_colors_info=”{%22gcid-body-color%22:%91%22background_color_gradient_stops%22%93,%22gcid-6bc66947-4928-4064-aa5f-8b610795df9b%22:%91%22background_color_gradient_stops%22%93}” box_shadow_color__hover_enabled=”off|hover” box_shadow_color__hover=”rgba(0,0,0,0)” transform_styles__hover_enabled=”on|hover” transform_scale__hover_enabled=”on|hover” transform_translate__hover_enabled=”on|desktop” transform_rotate__hover_enabled=”on|desktop” transform_skew__hover_enabled=”on|desktop” transform_origin__hover_enabled=”on|desktop” transform_scale__hover=”101%|101%” sticky_enabled=”0″]<\/p>\n European Commission<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”||||||||” text_text_color=”#FFFFFF” text_font_size=”15px” text_line_height=”1.8em” use_background_color_gradient=”on” background_color_gradient_direction=”200deg” background_color_gradient_stops=”gcid-6bc66947-4928-4064-aa5f-8b610795df9b 0%|#001f60 100%” width=”100%” max_width=”100%” max_width_tablet=”100%” max_width_phone=”100%” max_width_last_edited=”on|phone” custom_margin=”1px||22px||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”10px|20px|10px|20px|false|false” link_option_url=”https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02017R0745-20240709″ link_option_url_new_window=”on” hover_enabled=”0″ box_shadow_style=”preset2″ box_shadow_color=”rgba(0,0,0,0.16)” saved_tabs=”all” global_colors_info=”{%22gcid-body-color%22:%91%22background_color_gradient_stops%22%93,%22gcid-6bc66947-4928-4064-aa5f-8b610795df9b%22:%91%22background_color_gradient_stops%22%93}” box_shadow_color__hover_enabled=”off|hover” box_shadow_color__hover=”rgba(0,0,0,0)” transform_styles__hover_enabled=”on|hover” transform_scale__hover_enabled=”on|hover” transform_translate__hover_enabled=”on|desktop” transform_rotate__hover_enabled=”on|desktop” transform_skew__hover_enabled=”on|desktop” transform_origin__hover_enabled=”on|desktop” transform_scale__hover=”101%|101%” sticky_enabled=”0″]<\/p>\n EU Regulation 2017\/745 MDR<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”||||||||” text_text_color=”#FFFFFF” 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In order to obtain<\/strong> and above all, maintain<\/strong> European Union approval<\/strong> for the marketing of your medical device, there are several mandatory protocols, including CEP\/CER<\/strong> (Clinical Evaluation Plans and Reports) and BEP\/BER<\/strong> (Biological Evaluation Plans and Reports).<\/p>\n NewMed Consulting is committed to staying up-to-date <\/strong>with the latest regulations, documents, and protocols. The medical field is subject to stringent regulations that must be met, requiring specialized expertise<\/strong>. Over the years, our company has developed this expertise, making us one of the most experienced in industry.<\/p>\n Discover these and all the other protocols by contacting us now!<\/strong><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.27.3″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” border_color_all=”RGBA(255,255,255,0)” global_colors_info=”{}”][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” background_color=”#0a0000″ width=”100%” max_width=”100%” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][dipi_carousel space_between=”7″ speed=”4901″ loop_wide=”on” autoplay_wide=”on” continues_wide=”on” columns_tablet=”3″ columns_phone=”1″ columns_last_edited=”on|phone” module_class=”carosello” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”1px||||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”0px|||||” global_colors_info=”{}”][dipi_carousel_child img_src=”https:\/\/www.newmedconsulting.com\/wp-content\/uploads\/2024\/12\/documentazione-tecnica-di-prodotto-1.webp” alt=”documentazione-tecnica-di-prodotto-1″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/dipi_carousel_child][dipi_carousel_child img_src=”https:\/\/www.newmedconsulting.com\/wp-content\/uploads\/2024\/12\/documentazione-tecnica-di-prodotto-2.webp” alt=”documentazione-tecnica-di-prodotto-2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/dipi_carousel_child][dipi_carousel_child img_src=”https:\/\/www.newmedconsulting.com\/wp-content\/uploads\/2024\/12\/documentazione-tecnica-di-prodotto-3.webp” alt=”documentazione-tecnica-di-prodotto-3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/dipi_carousel_child][dipi_carousel_child img_src=”https:\/\/www.newmedconsulting.com\/wp-content\/uploads\/2024\/12\/documentazione-tecnica-di-prodotto-4.webp” alt=”documentazione-tecnica-di-prodotto-4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/dipi_carousel_child][dipi_carousel_child img_src=”https:\/\/www.newmedconsulting.com\/wp-content\/uploads\/2024\/12\/documentazione-tecnica-di-prodotto-5.webp” alt=”documentazione-tecnica-di-prodotto-5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/dipi_carousel_child][\/dipi_carousel][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”section” _builder_version=”4.27.3″ _module_preset=”default” custom_padding=”70px||40px|||” animation_style=”zoom” global_module=”178″ saved_tabs=”all” collapsed=”off” global_colors_info=”{}”][et_pb_row column_structure=”3_5,2_5″ use_custom_gutter=”on” make_equal=”on” admin_label=”row” _builder_version=”4.27.3″ _module_preset=”default” background_size=”initial” background_position=”top_left” background_repeat=”repeat” width=”90%” width_tablet=”90%” width_phone=”90%” width_last_edited=”on|tablet” max_width_tablet=”90%” max_width_phone=”90%” max_width_last_edited=”on|phone” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text admin_label=”Testo” _builder_version=”4.27.4″ _module_preset=”default” text_font=”–et_global_body_font|300|||||||” text_text_color=”#000000″ text_font_size=”26px” text_line_height=”1em” custom_margin=”-12px||||false|false” custom_margin_tablet=”-22px||||false|false” custom_margin_phone=”-22px||||false|false” custom_margin_last_edited=”on|phone” text_font_size_tablet=”” text_font_size_phone=”25px” text_font_size_last_edited=”on|phone” text_orientation_tablet=”” text_orientation_phone=”center” text_orientation_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n Would you like more information? 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PROTOCOLS: DEVELOPMENT AND EMISSION<\/h2>\n
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