{"id":1337,"date":"2023-03-27T13:23:14","date_gmt":"2023-03-27T13:23:14","guid":{"rendered":"https:\/\/sqiweb.wpengine.com\/qualite-reglementaire\/"},"modified":"2025-10-23T09:31:06","modified_gmt":"2025-10-23T09:31:06","slug":"qualite-reglementaire","status":"publish","type":"page","link":"https:\/\/sqi.coop\/en\/qualite-reglementaire\/","title":{"rendered":"Quality and regulatory"},"content":{"rendered":"

[et_pb_section fb_built=”1″ admin_label=”Header” module_class=”header-page-section gradient qara” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_row module_class=”header-page-row teal-text” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Surtitre” module_class=”subtitle-module center” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”5%” locked=”off” global_colors_info=”{}”]Quality and regulatory[\/et_pb_text][et_pb_cta title=”Bring support for quality
and regulatory affairs” admin_label=”Titre” module_class=”header-page-title qara” _builder_version=”4.21.0″ _module_preset=”default” header_level=”h1″ background_layout=”light” global_colors_info=”{}”]Certify your medical innovation in the best optimized and most secure way. [\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”De la recherche au march\u00e9” module_class=”market-section dark-text” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_row admin_label=”Titre Section” module_class=”title-row” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Surtitre” module_class=”subtitle-module center” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”5%” locked=”off” global_colors_info=”{}”]Tailor-made regulatory support[\/et_pb_text][et_pb_cta title=”From research to market” admin_label=”Titre” module_class=”title-module dark-text” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”2%” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”market-row” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Any type of structure” admin_label=”Tout type de structure” module_class=”market-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”]Laboratories, hospitals, project leaders, startups, leading companies, our offers are customized to fit any type of organisation, regardless of their size, objectives, and resources.[\/et_pb_blurb][et_pb_blurb title=”A diversity of innovative products” admin_label=”Une diversit\u00e9 de produits innovants” module_class=”market-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_delay=”200ms” global_colors_info=”{}”]Implantable Medical Devices, electromedical, in vitro diagnostics, clinical decision support software, telemonitoring, and more! Our experience helps us assist you on various topics.[\/et_pb_blurb][et_pb_blurb title=”Anytime” admin_label=”A tout moment” module_class=”market-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_delay=”400ms” global_colors_info=”{}”]We can step in and assist you at any moment during the product certification cycle, regardless of maturity or need.[\/et_pb_blurb][et_pb_blurb title=”Strong expertise in software regulation” admin_label=”Une expertise en r\u00e9glementation logicielle” module_class=”market-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_delay=”600ms” global_colors_info=”{}”]We support you on all topics pertaining to quality and regulation of medical devices, specifically on software (62304, AI, cybersecurity, telemonitoring, etc.).[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”5 accompagnements flexibles” module_class=”expertise-header-section qara” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ module_class=”expertise-header-row qara” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ module_class=”expertise-header-col-img” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_image alt=”4444″ title_text=”23″ module_class=”expertise-header-img legend” _builder_version=”4.21.0″ _module_preset=”default” background_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-header.jpg” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_2″ module_class=”expertise-header-col-title” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”flexible services” admin_label=”5 accompagnements flexibles” module_class=”expertise-header-title qara” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” animation_style=”fade” locked=”off” global_colors_info=”{}”]We offer services for all types of medical devices, including in vitro diagnostics. They cater to specific expectations and needs and can be activated independently from each other.[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”expertise-anchors-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_menu menu_id=”28″ admin_label=”Ancres” module_class=”expertise-anchors-module” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_menu][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Strat\u00e9gie r\u00e9glementaire” module_id=”regulatory-strategy” module_class=”accompagnement-section anchor” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_row module_class=”accompagnement-title-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Regulatory strategy” admin_label=”Titre” module_class=”accompagnement-title-module” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”accompagnement-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Description” module_class=”accompagnement-description” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]The objective: providing for your product the optimal regulatory roadmap to access the European or American market. The strategy involves among other things the product classification, clinical claims, critical points to be wary of delays and certification costs.[\/et_pb_text][et_pb_text admin_label=”Finalit\u00e9” module_class=”accompagnement-finality” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]Give credibility to your project at a regulatory level, support fundraising, bring clarity on your organization, roadmap, major milestones to be reached and necessary means.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Investigations cliniques” module_id=”clinical-investigations” module_class=”accompagnement-section anchor” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_row module_class=”accompagnement-title-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Clinical investigations” admin_label=”Titre” module_class=”accompagnement-title-module” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”accompagnement-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Description” module_class=”accompagnement-description” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]We support you on product design and building of the regulatory file ahead of its submission to competent authorities (ANSM, CPP). Furthermore, our ISO 13485 certification helps us take charge of regulatory compliance for unmarked CE devices for clinical investigations.[\/et_pb_text][et_pb_text admin_label=”Finalit\u00e9” module_class=”accompagnement-finality” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]Get help for your prototype design, delegate the regulatory manufacturer\u2019s responsibility and jumpstart your clinical investigation![\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Frise 3 images” module_class=”accompagnement-img-section” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_row module_class=”accompagnement-img-row” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][dipl_image_card_carousel space_between_slides=”0px” slider_loop=”on” show_control_dot=”on” control_dot_active_color=”#00f4eb” control_dot_inactive_color=”rgba(0,244,235,0.3)” cards_per_slide_tablet=”3″ cards_per_slide_phone=”1″ cards_per_slide_last_edited=”on|tablet” disabled_on=”off|off|off” admin_label=”Carousel” module_class=”accompagnement-img-module” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][dipl_image_card_carousel_item title=”Brain Computer Interface – CEA \/ Clinatec” image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-slider-1.jpg” _builder_version=”4.21.0″ _module_preset=”default” link_option_url=”#” global_colors_info=”{}”][\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=” Magia: MagIA\u00a9 Produit non marqu\u00e9 CE” image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-slider-2.jpg” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Braincam – Iconeus” image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-slider-3.jpg” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Twim In Motion – Modjaw” image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-slider-4.jpg” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Canule de trach\u00e9otomie sur mesure – SATT Paris-Saclay” image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-slider-6.jpg” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_image_card_carousel_item][dipl_image_card_carousel_item title=”Analyse du mucus – Rheonova” image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-slider-5.jpg” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_image_card_carousel_item][\/dipl_image_card_carousel][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Marquage CE \/ FDA” module_id=”marking” module_class=”accompagnement-section anchor” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_row module_class=”accompagnement-title-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”CE\/FDA market authorisation” admin_label=”Titre” module_class=”accompagnement-title-module” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”accompagnement-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Description” module_class=”accompagnement-description” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]Throughout the design and industrialization phases, we support you in ensuring that your deliverables reach the level of quality expected by the authorities. We review your technical files, assist you during submission and exchanges with the authorities. In case of product changes, we help you to update documentation and get necessary clearance.[\/et_pb_text][et_pb_text admin_label=”Finalit\u00e9” module_class=”accompagnement-finality” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]Secure the development of your product and the granting of commercial authorization thanks to the assistance of our referenced experts.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Syst\u00e8me de management de la qualit\u00e9” module_id=”quality-management-system” module_class=”accompagnement-section anchor” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_row module_class=”accompagnement-title-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Quality management
system” admin_label=”Titre” module_class=”accompagnement-title-module” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”accompagnement-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Description” module_class=”accompagnement-description” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]We assist you in setting up your quality management system (QMS), certified ISO 13485 or 21CFR Part.820.[\/et_pb_text][et_pb_text admin_label=”Finalit\u00e9” module_class=”accompagnement-finality” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]Ensure that your QMS is the best suited for your type of structure, products and experience in the field.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Accompagnements sp\u00e9cifiques” module_id=”specific-expertise” module_class=”accompagnement-section anchor” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_direction=”bottom” global_colors_info=”{}”][et_pb_row module_class=”accompagnement-title-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Specific expertise” admin_label=”Titre” module_class=”accompagnement-title-module” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”accompagnement-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Description” module_class=”accompagnement-description” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]On top of that, we also intervene on various topics related to regulatory: training onspecific standards, audit of your activities according to the ISO 13495 or IEC 62304 standards, audit of your subcontractors and many more.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”R\u00e9f\u00e9rentiels d’expertises” module_class=”referentials-section” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_row admin_label=”Titre” module_class=”title-row dark-text” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Standards of expertise” admin_label=”Titre” module_class=”title-module” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”2%” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”referentials-row” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_slider arrows_custom_color=”#002632″ dot_nav_custom_color=”#002632″ module_class=”referentials-module” _builder_version=”4.21.0″ _module_preset=”default” auto=”on” auto_speed=”5000″ global_colors_info=”{}”][et_pb_slide _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}” sticky_transition=”on”]<\/p>\n

\n
Quality management
system<\/h5>\n

\"\"
\n13485<\/span>\n<\/div>\n

\n
Quality management
system<\/h5>\n

\"\"
\n21 CFR 820<\/span>\n<\/div>\n

\n
Risk management<\/h5>\n

\"\"
\n14971<\/span>\n<\/div>\n

\n
Usability<\/h5>\n

\"\"
\n62366<\/span>\n<\/div>\n

[\/et_pb_slide][et_pb_slide _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}” sticky_transition=”on”]<\/p>\n

\n
Medical Device
Regulation<\/h5>\n

\"\"
\n2017 \/ 745 \/ CE<\/span>\n<\/div>\n

\n
In vitro diagnostic medical
device regulation<\/h5>\n

\"\"
\n2017 \/ 746 \/ CE<\/span>\n<\/div>\n

\n
FDA<\/h5>\n

\"\"
\n510(k)<\/span>\n<\/div>\n

[\/et_pb_slide][et_pb_slide _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}” sticky_transition=”on”]<\/p>\n

\n
Cybersecurity<\/h5>\n

\"\"
\n81001-5-1<\/span>\n<\/div>\n

\n
Artificial
intelligence<\/h5>\n

\"\"
\nIA Act<\/span>\n<\/div>\n

\n
Health software<\/h5>\n

\"\"
\n82304<\/span>\n<\/div>\n

\n
Medical
device software<\/h5>\n

\"\"
\n62304<\/span>\n<\/div>\n

[\/et_pb_slide][et_pb_slide _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}” sticky_transition=”on”]<\/p>\n

\n
Electromedical<\/h5>\n

\"\"
\n60601<\/span>\n<\/div>\n

\n
Active implants<\/h5>\n

\"\"
\n45502<\/span>\n<\/div>\n

\n
Biocompatibility<\/h5>\n

\"\"
\n10993<\/span>\n<\/div>\n

\n
Sterile packaging<\/h5>\n

\"\"
\n11607<\/span>\n<\/div>\n

\n
Sterilization<\/h5>\n

\"\"
\n11135<\/span>\n<\/div>\n

\n
Sterilization<\/h5>\n

\"\"
\n11137<\/span>\n<\/div>\n

[\/et_pb_slide][\/et_pb_slider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Nos succ\u00e8s” module_class=”success-section” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_row admin_label=”Titre” module_class=”title-row dark-text” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Surtitre” module_class=”subtitle-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”5%” locked=”off” global_colors_info=”{}”]Key figures[\/et_pb_text][et_pb_cta title=”Our successes” admin_label=”Titre” module_class=”title-module” _builder_version=”4.21.0″ _module_preset=”default” background_layout=”light” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”2%” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”success-row” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”10+” admin_label=”Marquages CE” module_class=”success-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”]CE markings[\/et_pb_blurb][et_pb_blurb title=”10+” admin_label=”CertificationsISO 13485 obtenues” module_class=”success-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”]ISO 13485 certifications granted[\/et_pb_blurb][et_pb_blurb title=”20+” admin_label=”Autorisations d’investigation clinique obtenues” module_class=”success-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”]clinical investigation authorizations granted[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Notre philosophie de travail” module_class=”philosophy-section dark-text” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_row admin_label=”Titre Section” module_class=”title-row” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Surtitre” module_class=”subtitle-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”5%” locked=”off” global_colors_info=”{}”]More than a contractor, a true partner[\/et_pb_text][et_pb_cta title=”Our work philosophy” admin_label=”Titre” module_class=”title-module dark-text” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”2%” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”philosophy-row” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Adapt” admin_label=”S\u2019adapter” module_class=”philosophy-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”]Resources allocated to your project are dimensioned based on your progress and upcoming milestones[\/et_pb_blurb][et_pb_blurb title=”Alert” admin_label=”Alerter” module_class=”philosophy-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_delay=”200ms” global_colors_info=”{}”]We anticipate project sticking points and communicate with you early enough to ensure they are integrated in the global roadmap.[\/et_pb_blurb][et_pb_blurb title=”Transfer knowledge” admin_label=”Transmettre” module_class=”philosophy-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_delay=”400ms” global_colors_info=”{}”]Along the project, we train your QARA resources to ensure your full autonomy and the sustainability of the project.[\/et_pb_blurb][et_pb_blurb title=”Facilitate” admin_label=”Faciliter” module_class=”philosophy-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_delay=”600ms” global_colors_info=”{}”]We participate in your discussions with subcontractors, notified bodies and competent authorities to help you understand better the information gathered and provide answers to any question.[\/et_pb_blurb][et_pb_blurb title=”At your side” admin_label=”A vos c\u00f4t\u00e9s” module_class=”philosophy-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” animation_delay=”800ms” global_colors_info=”{}”]We value the human touch and thus intersperse remote work with visits on your premises at key moments of the project. We help you own the solutions implemented.[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”philosophy-img-row” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_image title_text=”qara-philosophie” module_class=”philosophy-img” _builder_version=”4.20.2″ _module_preset=”default” background_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/qara-philosophie.jpg” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Nos points forts” module_class=”strong-section gradient qara” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_row admin_label=”Titre Section” module_class=”title-row teal-text” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Surtitre” module_class=”subtitle-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”5%” locked=”off” global_colors_info=”{}”]QARA expertise[\/et_pb_text][et_pb_cta title=”Our strong points” admin_label=”Titre” module_class=”title-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”2%” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”strong-list” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”An experienced team” open=”on” admin_label=”Une \u00e9quipe exp\u00e9riment\u00e9e” module_class=”strong-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”]Our team members come from various horizons and have a strong operational experience. They support you on regulatory and design challenges and leverage on lessons learned on technical issues or subcontractor management.[\/et_pb_toggle][et_pb_toggle title=”Varied expertise” admin_label=”Une expertise vari\u00e9e” module_class=”strong-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”]Biocompatibility, sterilization, cybersecurity, telemonitoring, usability, artificial intelligence, process validation, etc. Our experts can assist in most of the challenges you may face.[\/et_pb_toggle][et_pb_toggle title=”Close ties between our software and regulatory teams” admin_label=”Des liens \u00e9troits entre nos deux p\u00f4les logiciel et r\u00e9glementaire” module_class=”strong-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”]Our two departments work in close collaboration, allowing technical software experts to be involved in regulatory projects, and conversely.[\/et_pb_toggle][et_pb_toggle title=”Institutional recognition” admin_label=”Une reconnaissance institutionnelle” module_class=”strong-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”]Our consultants are referenced as experts by Bpifrance (public investments bank) and others institutions.[\/et_pb_toggle][et_pb_toggle title=”Delegation of manufacturer\u2019s responsibility” admin_label=”Une d\u00e9l\u00e9gation de la responsabilit\u00e9 de fabricant” module_class=”strong-module” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_colors_info=”{}”]A structure able to endorse manufacturer\u2019s responsibility on your behalf for a clinical investigation through our ISO 13485 certification.[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Logos et Partenaires” module_class=”logos-section” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_row admin_label=”Titre Section” module_class=”title-row” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Surtitre” module_class=”subtitle-module center” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”5%” locked=”off” global_colors_info=”{}”]Customers & Partners[\/et_pb_text][et_pb_cta title=”They trust us” admin_label=”Titre” module_class=”title-module dark-text” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”2%” global_colors_info=”{}”][\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”logos-row” _builder_version=”4.20.2″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][dipl_logo_slider logo_per_slide=”4″ space_between_slides=”0px” slider_loop=”on” show_arrow_on_hover=”on” arrows_position=”outside” show_control_dot=”off” slide_image_width=”250px” slide_image_height=”83px” arrow_font_size=”24px” arrow_color=”#002632″ slider_container_custom_padding=”||||false|false” logo_per_slide_tablet=”3″ logo_per_slide_phone=”1″ logo_per_slide_last_edited=”on|phone” admin_label=”Liste des logos” module_class=”logos-module” _builder_version=”4.21.0″ _module_preset=”default” width=”100%” max_width=”100%” min_height=”83px” height=”83px” max_height=”83px” custom_margin=”|20px||20px|false|false” locked=”off” global_colors_info=”{}”][dipl_logo_slider_item logo_alt=”CHU GA” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/chuga-1.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”Medtronic – Medicrea” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/medtronic.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”Seqone” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/seqone.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”CEA” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/cea-2.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”MagiA” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/magia-2.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”Pelican Health” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/pelican-1.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”Moon Surgical” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/moon.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”IHU Strasbourg” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/ihustrasbourg.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”AGIR \u00e0 dom” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/agiradom.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”SATT Paris-Saclay” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/satt.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][dipl_logo_slider_item logo_alt=”X-Pressure” upload_logo_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/05\/xpressure.png” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/dipl_logo_slider_item][\/dipl_logo_slider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Parlons de votre projet” module_class=”contact-cta-section gradient expertise” _builder_version=”4.20.2″ _module_preset=”default” saved_tabs=”all” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”2_5,3_5″ module_class=”contact-cta-row” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_5″ module_class=”contact-cta-col-slider” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_slider show_arrows=”off” show_pagination=”off” use_bg_overlay=”off” use_text_overlay=”off” disabled_on=”off|off|off” module_class=”contact-cta-slider” _builder_version=”4.21.0″ _module_preset=”default” background_enable_color=”off” background_enable_image=”off” auto=”on” auto_speed=”5000″ hover_enabled=”0″ locked=”off” global_colors_info=”{}” sticky_enabled=”0″][et_pb_slide admin_title=”BGA” _builder_version=”4.21.0″ _module_preset=”default” background_enable_color=”off” background_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/home-1.jpg” background_enable_image=”on” locked=”off” global_colors_info=”{}” sticky_transition=”on”][\/et_pb_slide][et_pb_slide admin_title=”LLE” _builder_version=”4.21.0″ _module_preset=”default” background_enable_color=”off” background_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/21.jpg” background_enable_image=”on” locked=”off” global_colors_info=”{}” sticky_transition=”on”][\/et_pb_slide][et_pb_slide admin_title=”CNE” _builder_version=”4.21.0″ _module_preset=”default” background_enable_color=”off” background_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/home-8.jpg” background_enable_image=”on” locked=”off” global_colors_info=”{}” sticky_transition=”on”][\/et_pb_slide][et_pb_slide admin_title=”LMB” _builder_version=”4.21.0″ _module_preset=”default” background_enable_color=”off” background_image=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/home-10.jpg” background_enable_image=”on” locked=”off” global_colors_info=”{}” sticky_transition=”on”][\/et_pb_slide][\/et_pb_slider][\/et_pb_column][et_pb_column type=”3_5″ module_class=”contact-cta-col-text” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta title=”Learn more about” button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQxIn19@” button_text=”Contact us” admin_label=”En savoir plus” module_class=”contact-cta-module” _builder_version=”4.21.0″ _dynamic_attributes=”button_url” _module_preset=”default” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”3%” global_colors_info=”{}”]Our quality and
regulatory support<\/span>
\nDo you have a project or specific need?
Let\u2019s discuss.[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|off” module_class=”footer-row” _builder_version=”4.21.0″ _module_preset=”default” animation_style=”fade” global_module=”1507″ saved_tabs=”all” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/03\/logo-sqi-baseline.svg” title_text=”logo-sqi-baseline” admin_label=”Logo SQI” module_class=”footer-module-logosqi” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][et_pb_text admin_label=”Logos” module_class=”footer-module-logo” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]\"\"\"\"\"\"\"\"[\/et_pb_text][et_pb_text admin_label=”Adresse” module_class=”footer-infos-module” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”]2 chemin du Vieux Ch\u00eane,
\n38240 Meylan, France<\/a><\/p>\n

+33(0)4 58 00 38 08<\/a><\/p>\n

\"\"<\/a>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”footer-mentions-row” _builder_version=”4.20.2″ _module_preset=”default” animation_style=”fade” saved_tabs=”all” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_menu menu_id=”8″ admin_label=”Mentions” module_class=”footer-mentions-module” _builder_version=”4.20.2″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_menu][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

Quality and regulatoryCertify your medical innovation in the best optimized and most secure way. Tailor-made regulatory supportLaboratories, hospitals, project leaders, startups, leading companies, our offers are customized to fit any type of organisation, regardless of their size, objectives, and resources.Implantable Medical Devices, electromedical, in vitro diagnostics, clinical decision support software, telemonitoring, and more! Our experience […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"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-1337","page","type-page","status-publish","hentry"],"yoast_head":"\nQuality and regulatory - SQI<\/title>\n<meta name=\"description\" content=\"Un accompagnement personnalis\u00e9, de votre strat\u00e9gie r\u00e9glementaire \u00e0 la certification, en passant par l\u2019investigation clinique.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sqi.coop\/en\/qualite-reglementaire\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality and regulatory - SQI\" \/>\n<meta property=\"og:description\" content=\"Un accompagnement personnalis\u00e9, de votre strat\u00e9gie r\u00e9glementaire \u00e0 la certification, en passant par l\u2019investigation clinique.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sqi.coop\/en\/qualite-reglementaire\/\" \/>\n<meta property=\"og:site_name\" content=\"SQI\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-23T09:31:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/logo-iso13485.svg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"15 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sqi.coop\/en\/qualite-reglementaire\/\",\"url\":\"https:\/\/sqi.coop\/en\/qualite-reglementaire\/\",\"name\":\"Quality and regulatory - SQI\",\"isPartOf\":{\"@id\":\"https:\/\/sqi.coop\/#website\"},\"datePublished\":\"2023-03-27T13:23:14+00:00\",\"dateModified\":\"2025-10-23T09:31:06+00:00\",\"description\":\"Un accompagnement personnalis\u00e9, de votre strat\u00e9gie r\u00e9glementaire \u00e0 la certification, en passant par l\u2019investigation clinique.\",\"breadcrumb\":{\"@id\":\"https:\/\/sqi.coop\/en\/qualite-reglementaire\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sqi.coop\/en\/qualite-reglementaire\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sqi.coop\/en\/qualite-reglementaire\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/sqi.coop\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Quality and regulatory\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sqi.coop\/#website\",\"url\":\"https:\/\/sqi.coop\/\",\"name\":\"SQI\",\"description\":\"Faciliter l\u2019innovation m\u00e9dicale\",\"publisher\":{\"@id\":\"https:\/\/sqi.coop\/#organization\"},\"alternateName\":\"SQI\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sqi.coop\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sqi.coop\/#organization\",\"name\":\"SQI\",\"url\":\"https:\/\/sqi.coop\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/sqi.coop\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/03\/logo-sqi-dark.svg\",\"contentUrl\":\"https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/03\/logo-sqi-dark.svg\",\"width\":1,\"height\":1,\"caption\":\"SQI\"},\"image\":{\"@id\":\"https:\/\/sqi.coop\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Quality and regulatory - SQI","description":"Un accompagnement personnalis\u00e9, de votre strat\u00e9gie r\u00e9glementaire \u00e0 la certification, en passant par l\u2019investigation clinique.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sqi.coop\/en\/qualite-reglementaire\/","og_locale":"en_US","og_type":"article","og_title":"Quality and regulatory - SQI","og_description":"Un accompagnement personnalis\u00e9, de votre strat\u00e9gie r\u00e9glementaire \u00e0 la certification, en passant par l\u2019investigation clinique.","og_url":"https:\/\/sqi.coop\/en\/qualite-reglementaire\/","og_site_name":"SQI","article_modified_time":"2025-10-23T09:31:06+00:00","og_image":[{"url":"https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/04\/logo-iso13485.svg"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"15 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sqi.coop\/en\/qualite-reglementaire\/","url":"https:\/\/sqi.coop\/en\/qualite-reglementaire\/","name":"Quality and regulatory - SQI","isPartOf":{"@id":"https:\/\/sqi.coop\/#website"},"datePublished":"2023-03-27T13:23:14+00:00","dateModified":"2025-10-23T09:31:06+00:00","description":"Un accompagnement personnalis\u00e9, de votre strat\u00e9gie r\u00e9glementaire \u00e0 la certification, en passant par l\u2019investigation clinique.","breadcrumb":{"@id":"https:\/\/sqi.coop\/en\/qualite-reglementaire\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sqi.coop\/en\/qualite-reglementaire\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/sqi.coop\/en\/qualite-reglementaire\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/sqi.coop\/en\/"},{"@type":"ListItem","position":2,"name":"Quality and regulatory"}]},{"@type":"WebSite","@id":"https:\/\/sqi.coop\/#website","url":"https:\/\/sqi.coop\/","name":"SQI","description":"Faciliter l\u2019innovation m\u00e9dicale","publisher":{"@id":"https:\/\/sqi.coop\/#organization"},"alternateName":"SQI","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sqi.coop\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/sqi.coop\/#organization","name":"SQI","url":"https:\/\/sqi.coop\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/sqi.coop\/#\/schema\/logo\/image\/","url":"https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/03\/logo-sqi-dark.svg","contentUrl":"https:\/\/sqiweb.wpengine.com\/wp-content\/uploads\/2023\/03\/logo-sqi-dark.svg","width":1,"height":1,"caption":"SQI"},"image":{"@id":"https:\/\/sqi.coop\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sqi.coop\/en\/wp-json\/wp\/v2\/pages\/1337","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sqi.coop\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sqi.coop\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sqi.coop\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/sqi.coop\/en\/wp-json\/wp\/v2\/comments?post=1337"}],"version-history":[{"count":0,"href":"https:\/\/sqi.coop\/en\/wp-json\/wp\/v2\/pages\/1337\/revisions"}],"wp:attachment":[{"href":"https:\/\/sqi.coop\/en\/wp-json\/wp\/v2\/media?parent=1337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}