[et_pb_section fb_built=”1″ admin_label=”top” _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”20px||||false|false” collapsed=”on” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.27.4″ _module_preset=”default” width=”60%” width_tablet=”90%” width_phone=”90%” width_last_edited=”on|tablet” module_alignment=”left” custom_padding=”|||10%|false|false” custom_padding_tablet=”|||0%|false|false” custom_padding_phone=”|||0%|false|false” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”Technical and Legislative Consultancy for EU Compliance” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” border_color_bottom=”#255AA6″ global_colors_info=”{}”]Since 2006, we have been helping companies overcome regulatory and bureaucratic barriers in Europe and worldwide. We analyze applicable directives and regulations, define action plans, produce and verify documentation, and conduct audits and production controls in Asia, reducing risks and timing.
In this way, we accelerate market access and strengthen product positioning through compliance and reliability.[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjIyIiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@” button_text=”Request consultation” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Chi siamo” _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”20px||20px||true|false” collapsed=”on” global_colors_info=”{}”][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”4.27.4″ _module_preset=”default” width=”60%” width_tablet=”80%” width_phone=”90%” width_last_edited=”on|tablet” custom_css_main_element=”align-items: center” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”|700||on|||||” text_text_color=”#255AA6″ text_font_size=”14px” global_colors_info=”{}”]<\/p>\n
About Us<\/p>\n
[\/et_pb_text][et_pb_heading title=”Experts in CE Marking and European Compliance” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]SQM is a leader in technical and legislative consultancy, guiding companies through the complex regulatory framework of the European Union. We operate across multiple sectors, offering tailor-made solutions to ensure compliance with international and local standards. Our experienced team supports clients in bringing products to market efficiently, meeting stringent EU requirements.[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjIyIiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@” button_text=”Contact Us” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][difl_imagemask image=”https:\/\/pass4ce.eu\/wp-content\/uploads\/2025\/09\/Chi-Siamo-1024×1024.png” mask_size=”100%” mask_position=”center_left” mask_select=”mask_image_03″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/difl_imagemask][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Mission” _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”20px||20px||true|false” collapsed=”on” global_colors_info=”{}”][et_pb_row column_structure=”2_5,3_5″ make_equal=”on” module_class=”invert-mobile” _builder_version=”4.27.4″ _module_preset=”default” width=”60%” width_tablet=”80%” width_phone=”90%” width_last_edited=”on|tablet” custom_css_main_element=”align-items: center” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][difl_imagemask image=”https:\/\/pass4ce.eu\/wp-content\/uploads\/2025\/09\/mission-1024×1024.png” mask_size=”100%” mask_position=”center_left” mask_select=”mask_image_03″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/difl_imagemask][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”|700||on|||||” text_text_color=”#255AA6″ text_font_size=”14px” global_colors_info=”{}”]<\/p>\n
Mission<\/p>\n
[\/et_pb_text][et_pb_heading title=”We make market access simple, fast, and secure.” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
We facilitate the free movement of goods across Europe by transforming regulatory complexity into practical, actionable steps. We map applicable directives and regulations, define adaptation plans, prepare and verify technical documentation and EU Declarations of Conformity, conduct audits and factory inspections (also in Asia), and complete the CE marking process up to sales readiness. Our goal is to reduce non-compliance risks, shorten time-to-market, and strengthen the competitiveness of your products through a clear, transparent, and measurable approach along the entire value chain. <\/p>\n
[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjIyIiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@” button_text=”Contact Us” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Storia” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#F5F3F3″ custom_padding=”20px||20px||true|false” collapsed=”on” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.27.4″ _module_preset=”default” width_tablet=”80%” width_phone=”90%” width_last_edited=”on|tablet” custom_css_main_element=”align-items: center” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”|700||on|||||” text_text_color=”#255AA6″ text_font_size=”14px” global_colors_info=”{}”]<\/p>\n
Our History<\/p>\n
[\/et_pb_text][et_pb_heading title=”From Regulatory Consultancy in Europe to Operational Management in China” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
Our story began with laboratory experience (EMC and LVD) and evolved into field operations: integrating consultancy, documentation, and production inspections to reduce risk and market entry times.<\/p>\n
[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjI2IiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@” button_text=”Discover Our Services” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][difl_iconlist list_item_gap=”1px” list_item_equal_width=”on” list_item_content_max_width=”100%” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][difl_iconlistitem list_item_title=”2006 \u2013 The Origins” list_item_icon=”$||divi||400″ list_item_title_padding=”|0px||0px|false|false” list_item_content_margin=”|0px||0px|false|false” list_item_content_padding=”|0px||0px|false|false” list_item_wrapper_margin=”|0px|||false|false” list_item_wrapper_padding=”|0px|||false|false” _builder_version=”4.27.4″ global_colors_info=”{}”]<\/p>\n
SQM was founded to provide specialized consultancy on regulatory compliance.
Its founder, Pietro Piras, brings extensive experience gained in EMC and LVD laboratories. <\/p>\n
[\/difl_iconlistitem][difl_iconlistitem list_item_title=”2014 \u2013 Presence in China” list_item_icon=”$||divi||400″ list_item_title_padding=”|0px||0px|false|false” list_item_content_margin=”|0px||0px|false|false” list_item_content_padding=”|0px||0px|false|false” list_item_wrapper_margin=”|0px|||false|false” list_item_wrapper_padding=”|0px|||false|false” _builder_version=”4.27.4″ global_colors_info=”{}”]<\/p>\n
Opening of the Shenzhen office to operate before import: manufacturer selection, supervision of the production process, in-production inspections, verification, and corrective actions to ensure compliance.<\/p>\n
[\/difl_iconlistitem][\/difl_iconlist][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Chi siamo” _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”20px||20px||true|false” collapsed=”on” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.27.4″ _module_preset=”default” width=”60%” width_tablet=”80%” width_phone=”90%” width_last_edited=”on|tablet” custom_css_main_element=”align-items: center” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”|700||on|||||” text_text_color=”#255AA6″ text_font_size=”14px” global_colors_info=”{}”]<\/p>\n
What We Do<\/p>\n
[\/et_pb_text][et_pb_heading title=”End-to-End Services for Market Access” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
We assist companies from regulatory analysis to implementation: translating EU requirements into concrete actions, verifying documentation, monitoring suppliers and production in Asia, and supporting go-to-market operations with full control over timing and quality.<\/p>\n
[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjIyIiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@” button_text=”Contact Us” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”EU and International Conformity” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We analyze applicable directives, regulations, and standards, identify gaps and risks, and define the adaptation path. We create a roadmap with clear priorities, responsibilities, and timelines to achieve compliance and maintain ongoing control. <\/p>\n
[\/et_pb_toggle][et_pb_toggle title=”CE Marking” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” hover_enabled=”0″ border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
We manage the entire process: conformity assessment, preparation of Technical Documentation, labeling, user instructions, and EU Declaration of Conformity. We coordinate testing and verification activities. <\/p>\n
[\/et_pb_toggle][et_pb_toggle title=”Quality & Process” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We design and optimize practices and quality systems that meet regulatory requirements and enable continuous improvement. We standardize controls, records, and responsibilities to reduce non-conformities, returns, and operational costs. <\/p>\n
[\/et_pb_toggle][et_pb_toggle title=”Pre-Import (China\/Asia)” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We select and qualify suppliers, supervise production, conduct inspections (pre-production, during production, pre-shipment), and verify product compliance. We activate corrective actions promptly to prevent issues before shipment. <\/p>\n
[\/et_pb_toggle][et_pb_toggle title=”Go-to-market” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We coordinate all final activities for market placement: document alignment, traceability, and inspection readiness. We support both technical and commercial teams to meet deadlines and fulfill authority and audit requirements while optimizing time-to-market. <\/p>\n
[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Storia” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#F5F3F3″ custom_padding=”20px||20px||true|false” collapsed=”on” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.27.4″ _module_preset=”default” width_tablet=”80%” width_phone=”90%” width_last_edited=”on|tablet” custom_css_main_element=”align-items: center” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”|700||on|||||” text_text_color=”#255AA6″ text_font_size=”14px” global_colors_info=”{}”]<\/p>\n
Why Choose SQM<\/p>\n
[\/et_pb_text][et_pb_heading title=”Compliance without surprises: expertise, efficiency, and a strong Europe\u2013China presence.” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
We combine in-depth knowledge of directives and regulations with an operational method that reduces non-compliance risks and accelerates time-to-market. With a presence in both Europe and China, we turn regulatory requirements into compliant, competitive products that strengthen your brand\u2019s reputation and market positioning. <\/p>\n
[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjI2IiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@” button_text=”Discover Our Services” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][difl_iconlist list_item_gap=”1px” list_item_equal_width=”on” list_item_content_max_width=”100%” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][difl_iconlistitem list_item_title=”EU Regulatory Expertise” list_item_icon=”$||divi||400″ list_item_title_padding=”|0px||0px|false|false” list_item_content_margin=”|0px||0px|false|false” list_item_content_padding=”|0px||0px|false|false” list_item_wrapper_margin=”|0px|||false|false” list_item_wrapper_padding=”|0px|||false|false” _builder_version=”4.27.4″ child_icon_text_text_color=”#252B42″ global_colors_info=”{}”]<\/p>\n
We interpret directives, regulations, and implementation guides, mapping applicable requirements and translating them into operational actions (evaluations, technical dossiers, labeling, declarations), ensuring complete regulatory compliance.<\/p>\n
[\/difl_iconlistitem][difl_iconlistitem list_item_title=”Operational Efficiency” list_item_icon=”$||divi||400″ list_item_title_padding=”|0px||0px|false|false” list_item_content_margin=”|0px||0px|false|false” list_item_content_padding=”|0px||0px|false|false” list_item_wrapper_margin=”|0px|||false|false” list_item_wrapper_padding=”|0px|||false|false” _builder_version=”4.27.4″ child_icon_text_text_color=”#252B42″ global_colors_info=”{}”]We define a roadmap with priorities and timelines, streamline procedures, and prevent non-conformities: fewer delays and reworks, faster time-to-market, and lower costs under full control.[\/difl_iconlistitem][difl_iconlistitem list_item_title=”Europe\u2013China Presence” list_item_icon=”$||divi||400″ list_item_title_padding=”|0px||0px|false|false” list_item_content_margin=”|0px||0px|false|false” list_item_content_padding=”|0px||0px|false|false” list_item_wrapper_margin=”|0px|||false|false” list_item_wrapper_padding=”|0px|||false|false” _builder_version=”4.27.4″ child_icon_text_text_color=”#252B42″ global_colors_info=”{}”]<\/p>\n
A single management system connecting regulatory consultancy in the EU with factory oversight in Asia: supplier selection and qualification.<\/p>\n
[\/difl_iconlistitem][difl_iconlistitem list_item_title=”Value for the Brand” list_item_icon=”$||divi||400″ list_item_title_padding=”|0px||0px|false|false” list_item_content_margin=”|0px||0px|false|false” list_item_content_padding=”|0px||0px|false|false” list_item_wrapper_margin=”|0px|||false|false” list_item_wrapper_padding=”|0px|||false|false” _builder_version=”4.27.4″ child_icon_text_text_color=”#252B42″ global_colors_info=”{}”]<\/p>\n
Compliant products and solid documentation strengthen the trust of clients and authorities, reduce the risk of sanctions or recalls, and enhance reputation and competitiveness in the long term.<\/p>\n
[\/difl_iconlistitem][\/difl_iconlist][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Chi siamo” _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”20px||20px||true|false” collapsed=”on” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.27.4″ _module_preset=”default” width=”60%” width_tablet=”80%” width_phone=”90%” width_last_edited=”on|tablet” custom_css_main_element=”align-items: center” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”|700||on|||||” text_text_color=”#255AA6″ text_font_size=”14px” global_colors_info=”{}”]<\/p>\n
How We Work<\/p>\n
[\/et_pb_text][et_pb_heading title=”From Requirements to Market Launch: Our 4-Step Method” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
We apply a clear and measurable process that reduces risks, time, and rework.
From the initial CE marking assessment to readiness for sale, we define responsibilities, deliverables, and milestones \u2014 coordinating tests, documentation, and factory checks to ensure solid and sustainable compliance. <\/p>\n
[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjIyIiwiZW5hYmxlX2h0bWwiOiJvZmYifX0=@” button_text=”Contact Us” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”1. Assessment” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We analyze the product, its intended use, and destination markets; we map applicable directives, regulations, and standards and identify technical and documentary gaps.
We assess risks, priorities, and cost\/time impacts, verify existing documentation (drawings, BOMs, manuals, etc.), and set up the compliance matrix that will guide all subsequent phases. <\/p>\n
[\/et_pb_toggle][et_pb_toggle title=”2. Action Plan” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We build an operational roadmap with activities, deadlines, and acceptance criteria. We plan testing and verification (laboratories, notified bodies), prepare templates and checklists for Technical Documentation and the Declaration of Conformity, define decision-making and reporting cadence, and align with suppliers and internal departments (R&D, quality, logistics). <\/p>\n
[\/et_pb_toggle][et_pb_toggle title=”3. Execution & Verification” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We draft and collect documents (technical file, manuals, labels), coordinate testing and inspections, carry out factory audits (pre-production, during production, pre-shipment), and verify batch compliance.
We activate corrective and preventive actions (CAPA), manage compliance updates, ensure traceability, and monitor changes until all non-conformities are closed. <\/p>\n
[\/et_pb_toggle][et_pb_toggle title=”4. Conformity & Release” open_toggle_text_color=”#252B42″ open_toggle_background_color=”#F5F3F3″ closed_toggle_background_color=”#F5F3F3″ icon_color=”#252B42″ toggle_icon=”3||divi||400″ use_icon_font_size=”on” icon_font_size=”30px” open_icon_color=”#252B42″ open_toggle_icon=”2||divi||400″ open_use_icon_font_size=”on” open_icon_font_size=”30px” _builder_version=”4.27.4″ _module_preset=”default” title_text_color=”#252B42″ title_level=”h6″ title_font_size=”18px” custom_margin=”||10px||false|false” custom_padding=”20px||20px||true|false” border_radii=”on|20px|20px|20px|20px” border_width_all=”0px” global_colors_info=”{}”]<\/p>\n
We finalize CE marking, EU Declaration of Conformity, and labeling\/instructions in the language of the destination country. We deliver the complete documentation file, align the team on post-market surveillance requirements, and define documentation retention and update procedures.
The product is ready for market placement, meeting deadlines and regulatory requirements, and is well prepared for audits and authority inspections. <\/p>\n
[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
Since 2006, we have been helping companies overcome regulatory and bureaucratic barriers in Europe and worldwide. We analyze applicable directives and regulations, define action plans, produce and verify documentation, and conduct audits and production controls in Asia, reducing risks and timing.In this way, we accelerate market access and strengthen product positioning through compliance and reliability.About […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"difl_page_category":[],"class_list":["post-281994","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/pages\/281994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/comments?post=281994"}],"version-history":[{"count":4,"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/pages\/281994\/revisions"}],"predecessor-version":[{"id":282170,"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/pages\/281994\/revisions\/282170"}],"wp:attachment":[{"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/media?parent=281994"}],"wp:term":[{"taxonomy":"difl_page_category","embeddable":true,"href":"https:\/\/www.pass4ce.eu\/en\/wp-json\/wp\/v2\/difl_page_category?post=281994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}