{"id":275,"date":"2024-01-27T20:19:19","date_gmt":"2024-01-27T20:19:19","guid":{"rendered":"https:\/\/mos-mtk.cn\/en\/?page_id=275"},"modified":"2024-02-22T14:35:46","modified_gmt":"2024-02-22T14:35:46","slug":"medical-device-testing","status":"publish","type":"page","link":"https:\/\/mos-mtk.cn\/en\/medical-device-testing\/","title":{"rendered":"Medical Device Testing"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; next_background_color=&#8221;#ffffff&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#fcfcfc&#8221; background_enable_image=&#8221;off&#8221; background_position=&#8221;top_center&#8221; background_blend=&#8221;overlay&#8221; background_enable_video_mp4=&#8221;off&#8221; width=&#8221;100%&#8221; module_alignment=&#8221;center&#8221; min_height=&#8221;1px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; bottom_divider_style=&#8221;curve&#8221; 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custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;||||false|true&#8221; text_text_color_tablet=&#8221;#FFFFFF&#8221; text_text_color_phone=&#8221;#000000&#8243; text_text_color_last_edited=&#8221;on|phone&#8221; header_text_color_tablet=&#8221;#FFFFFF&#8221; header_text_color_phone=&#8221;#000000&#8243; header_text_color_last_edited=&#8221;on|tablet&#8221; header_font_size_tablet=&#8221;&#8221; header_font_size_phone=&#8221;25px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;55px&#8221; header_2_font_size_phone=&#8221;35px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1>Medical Device<br \/>Testing Services<\/h1>\n<p>Conducting Mandatory Medical Device Testing in Compliance with Current Russian Regulatory Requirements.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;#form&#8221; button_text=&#8221;Application form&#8221; button_alignment=&#8221;left&#8221; 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position_origin_f_last_edited=&#8221;on|phone&#8221; position_origin_r_tablet=&#8221;&#8221; position_origin_r_phone=&#8221;&#8221; position_origin_r_last_edited=&#8221;on|phone&#8221; width=&#8221;300px&#8221; width_tablet=&#8221;300px&#8221; width_phone=&#8221;200px&#8221; width_last_edited=&#8221;on|phone&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;70px|30px|70px|40px|true|false&#8221; custom_padding_tablet=&#8221;70px|30px|70px|40px|true|false&#8221; custom_padding_phone=&#8221;40px|40px|40px|40px|true|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; header_3_font_size_tablet=&#8221;35px&#8221; header_3_font_size_phone=&#8221;20px&#8221; header_3_font_size_last_edited=&#8221;on|phone&#8221; transform_styles_tablet=&#8221;&#8221; transform_styles_phone=&#8221;&#8221; positioning_tablet=&#8221;absolute&#8221; positioning_phone=&#8221;absolute&#8221; positioning_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3>50 working<br \/>\ndays<\/h3>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/mos-mtk.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/01\/Toxicological-tests.webp&#8221; 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header_3_line_height_tablet=&#8221;1.7em&#8221; header_3_line_height_phone=&#8221;1.2em&#8221; header_3_line_height_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3>Technical tests<\/h3>\n<p>Conducting tests in accredited laboratories to confirm the compliance of a medical device with the technical and operational documentation of the manufacturer, as well as the requirements of applicable standards.<br \/>Electromagnetic compatibility (EMC) tests are also carried out on all electrical products.<\/p>\n<p><strong>We select a testing laboratory taking into account applicable standards and test methods:<\/strong><\/p>\n<p><strong>Import of samples<\/strong><\/p>\n<ul>\n<li>Import of samples to Russia for testing<\/li>\n<\/ul>\n<p><strong>Expert visit to the MD installation site<\/strong><\/p>\n<ul>\n<li>Applicable for products that require permits (licenses) for installation, creation of special conditions, construction of individual capital structures, etc.<\/li>\n<\/ul>\n<p><strong>Required documents:<\/strong><\/p>\n<ul>\n<li>Technical and operational documentation<\/li>\n<li>Test-reports on applicable standards<\/li>\n<li>Risk management report<\/li>\n<li>Usability engineering file<\/li>\n<li>Validation and verification report for MD and software<\/li>\n<li>Essential requirements<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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custom_padding_last_edited=&#8221;on|phone&#8221; header_3_font_size_tablet=&#8221;35px&#8221; header_3_font_size_phone=&#8221;20px&#8221; header_3_font_size_last_edited=&#8221;on|phone&#8221; positioning_tablet=&#8221;absolute&#8221; positioning_phone=&#8221;absolute&#8221; positioning_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3>30 working days<\/h3>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/mos-mtk.cn\/en\/wp-content\/uploads\/sites\/2\/2024\/01\/clinical-trials2.webp&#8221; title_text=&#8221;clinical trials2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||-3px|||&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;3_5&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.24.1&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#1b1b1b&#8221; text_line_height=&#8221;1.6em&#8221; header_3_font=&#8221;|800|||||||&#8221; header_3_font_size=&#8221;35px&#8221; header_3_line_height=&#8221;1.3em&#8221; header_4_font_size=&#8221;25px&#8221; header_4_line_height=&#8221;1.4em&#8221; custom_margin=&#8221;||7px|||&#8221; custom_margin_tablet=&#8221;&#8221; custom_margin_phone=&#8221;2px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; hover_enabled=&#8221;0&#8243; header_3_font_size_tablet=&#8221;55px&#8221; header_3_font_size_phone=&#8221;35px&#8221; header_3_font_size_last_edited=&#8221;on|phone&#8221; header_3_line_height_tablet=&#8221;1.7em&#8221; header_3_line_height_phone=&#8221;1.2em&#8221; header_3_line_height_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h3>Clinical trials<\/h3>\n<p>Tests are carried out in accredited clinics in the form of research or in the form of trials, carried out to evaluate the safety and effectiveness of a medical device.<\/p>\n<blockquote>\n<p><i>Our<\/i> <i>company\u2019s<\/i> <i>specialists<\/i> <i>analyze<\/i> <i>available<\/i> <i>documents<\/i><i>, <\/i><i>conduct<\/i><i> a <\/i><i>literature<\/i> <i>search<\/i><i>, <\/i><i>analogues<\/i><i>,<\/i><i> etc.,<\/i> <i>request<\/i> <i>additional<\/i> <i>materials<\/i> <i>from<\/i> <i>the<\/i> <i>manufacturer<\/i> <i>and<\/i> <i>prepare<\/i> <i>an<\/i><i> Act, Program <\/i><i>and<\/i> <i>Clinical<\/i> <i>Trial<\/i><i> Protocol <\/i><i>for<\/i> <i>subsequent<\/i> <i>approval<\/i> <i>by<\/i> <i>the<\/i> <i>hospital<\/i><i>.<\/i><\/p>\n<\/blockquote>\n<ul>\n<li>Clinical trials of medical devices are conducted in the form of analysis and evaluation of clinical data.\n<p><b><i>(If MD is not a new type, and it does not use new complex and (or) unique and (or) special methods and medical technologies etc.)<\/i><\/b><\/p>\n<\/li>\n<li>The sample of the medical device is also examined during trials.<\/li>\n<li>If the product is not imported into the territory of the Russian Federation, we will organize a specialist visit to the MD installation site (Applicable for products that require permits (licenses) for installation etc.)<\/li>\n<\/ul>\n<p><b>Required documents<\/b><b>:<\/b><\/p>\n<ul>\n<li>Technical and operational documentation<\/li>\n<li>Protocols of toxicological, technical and other tests carried out for registration;<\/li>\n<li>Documents containing data on the clinical use of a medical device, including outside the Russian Federation, including reviews, reports on scientific research, publications, reports, risk analysis of use, methods of using a medical device (if available);<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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