{"id":188719,"date":"2022-05-28T02:04:50","date_gmt":"2022-05-28T09:04:50","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/software-as-a-medical-device-samd-translations\/"},"modified":"2023-03-09T19:58:04","modified_gmt":"2023-03-10T02:58:04","slug":"%e8%bd%af%e4%bb%b6%e5%8d%b3%e5%8c%bb%e7%96%97%e8%ae%be%e5%a4%87samd%e7%bf%bb%e8%af%91","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%bd%af%e4%bb%b6%e5%8d%b3%e5%8c%bb%e7%96%97%e8%ae%be%e5%a4%87samd%e7%bf%bb%e8%af%91\/","title":{"rendered":"\u8f6f\u4ef6\u5373\u533b\u7597\u8bbe\u5907\uff08SAMD\uff09\u7ffb\u8bd1"},"content":{"rendered":"
[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ custom_margin=”|||” custom_padding=”0px|0px|0px|0px”][et_pb_fullwidth_header text_orientation=”center” button_one_text=”\u7acb\u5373\u8054\u7cfb\u6211\u4eec” button_one_url=”https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%81%94%e7%b3%bb\/” background_overlay_color=”rgba(0,0,0,0)” content_max_width=”84%” content_max_width_tablet=”” content_max_width_phone=”100%” content_max_width_last_edited=”on|phone” module_class=”hide-h1″ _builder_version=”4.5.3″ content_font=”||||||||” content_font_size=”22px” content_line_height=”1.6em” subhead_font=”||||||||” background_color=”rgba(255,255,255,0)” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/05\/medical-bg3-min.jpg” parallax=”on” parallax_method=”on” custom_button_two=”on” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”80px||80px|” custom_padding_tablet=”” custom_padding_phone=”50px||50px|” custom_padding_last_edited=”on|desktop” content_font_size_tablet=”” content_font_size_phone=”17px” content_font_size_last_edited=”on|desktop” button_one_text_size__hover_enabled=”off” button_one_text_size__hover=”null” button_two_text_size__hover_enabled=”off” button_two_text_size__hover=”null” button_one_text_color__hover_enabled=”off” button_one_text_color__hover=”null” button_two_text_color__hover_enabled=”off” button_two_text_color__hover=”null” button_one_border_width__hover_enabled=”off” button_one_border_width__hover=”null” button_two_border_width__hover_enabled=”off” button_two_border_width__hover=”null” button_one_border_color__hover_enabled=”off” button_one_border_color__hover=”null” button_two_border_color__hover_enabled=”off” button_two_border_color__hover=”null” button_one_border_radius__hover_enabled=”off” button_one_border_radius__hover=”null” button_two_border_radius__hover_enabled=”off” button_two_border_radius__hover=”null” button_one_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover=”null” button_two_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover=”null” button_one_bg_color__hover_enabled=”off” button_one_bg_color__hover=”null” button_two_bg_color__hover_enabled=”off” button_two_bg_color__hover=”null”]<\/p>\n
We offer high-quality software as a medical device (SaMD) translations and localization solutions in 250+ languages to reach new markets and patients on a global scale[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”23px|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ custom_padding=”0|0px|0|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”]<\/p>\n
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In the medical field, software has a growing place in accelerating our ability to discover, manage, and treat all types of conditions, which makes Software as a Medical Device (SaMD) translations essential for integrating this technology into global medical markets. By U.S. Food and Drug Administration (FDA) standards, SaMD is any software that carries out medical functions without the need for actual hardware. SaMD plays a specific role within medical devices and healthcare operations, including as the software used to control infusion pump motors and the software that enables medical communications, like video calling, scheduling appointments, and digital patient registration. More broadly, the applications of SaMD platforms include diagnosing and screening, monitoring and alerting, disease and condition management, and digital therapeutics. Since SaMD is relatively new, finding its place in the digital health space has prompted regulators, including the FDA, EMA, and International Medical Device Regulators Forum (IMDRF), to actively develop guidance and framework to help promote safe innovation and uphold patient protections.
\nAs SaMD platforms continue to advance, the global integration of this technology demands that the materials and content necessary for driving this growth be available in any language and tailored to the needs of any market. To help companies safely and efficiently bring this technology overseas, CSOFT Health Sciences provides expert localization solutions and software as a medical device (SaMD) translations in over 250 languages.<\/p>\n
In addition to SaMD translations, our global network of linguists and subject matter experts offer a full range of medical translation and localization solutions for the medical device industry, including:[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||0px||false|false”][et_pb_column type=”1_2″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_text admin_label=”Text” _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_color=”#f9f9f9″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/05\/medical-bg2-min.jpg” parallax=”on”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_column type=”2_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_text_color=”#000000″ header_2_font=”||||||||” header_2_text_color=”#000000″]<\/p>\n
Medical software plays a broad function in healthcare systems today, from enabling doctors to view electronic health records (EHRs) to serving as a diagnostic tool like SaMD. As a multi-billion-dollar industry with rapid growth in recent years, medical software is the backbone of hospitals, outpatient clinics, and urgent care facilities, and enables medical workers to connect with patients and deliver high-quality care. To ensure that medical workers, patients, and manufactures of all backgrounds and languages can\u00a0operate and develop medical software to standards, it is necessary that the software be localized\u00a0and the linguistic elements be translated\u00a0to meet local needs. With a network of linguists and subject matter experts in medical software, CSOFT Health Sciences provides medical software localization including for UX\/UI strings, linguistic, function, and cosmetic testing, and DevOps continuous translation.<\/p>\n
In addition to software localization, we offer translations for the linguistic components of medical software, including\u00a0patient portal translations<\/u><\/a><\/span>.<\/p>\n Learn more\u00a0about our software localization<\/u><\/a><\/span>.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ parallax=”on” custom_padding=”0px||0px”][et_pb_row make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px||60px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_text_color=”#000000″ header_2_font=”||||||||” header_2_text_color=”#000000″ text_orientation=”center”]<\/p>\n When bringing medical devices to international markets, professional software localization for medical devices is critical in ensuring its global success across the product life cycle, as well as for the safety and efficacy of the therapy for patients. Medical device software translations\u00a0are similar to the standard localization\u00a0process: the software user interface (UI) strings are extracted and held in an external resource, before being translated into the desired languages and then recompiled back into the original source application. With this, however, linguistic validation, quality assurance, and testing for functionality as well as cosmetically are crucial for the overall success in\u00a0medical device software localization and translation.<\/p>\n CSOFT Health Sciences provides expert medical device software translation services. With a network of over 10,000 linguists located all over the world, who work with software engineers and project managers, we ensure the highest-quality translation for software for the best ROI.<\/p>\n Learn more\u00a0about our medical devices translation<\/u><\/a><\/span>.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_class=”bg-blue-dark” _builder_version=”4.5.3″ background_color=”#f9f9f9″ parallax=”on”][et_pb_row column_structure=”2_3,1_3″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_text_color=”#ffffff” text_font_size=”16px” header_font=”||||||||” header_2_font=”||||||||” header_2_text_color=”#ffffff” header_3_font=”||||||||” header_3_text_color=”#ffffff”]<\/p>\n In the space of digital medical solutions, mobile medical app\u00a0translations\u00a0have become an innovative tool for collecting valuable health data and monitoring, diagnosing, and discovering medical conditions on a global scale. On the side of the end user, mobile medical apps enable patients and patient proxies to schedule appointments, access health records, and even monitor vital signs or glucose level.\u00a0On the side of a provider, these apps have advanced to the level at which doctors can prescribe medication and diagnose conditions without ever interacting with the patient in person\u00a0by improving accessibility with remote visits. As the widespread deployment of this technology reaches\u00a0new markets and end users globally, translations of the linguistic content and regulations in place to develop medical apps are essential for growth. With proven experience in medical software localization and a global network of\u00a0over 10,000 subject matter expert\u00a0translators, CSOFT Health Sciences provides mobile medical app translations to help facilitate growth and reach new markets.<\/p>\n In addition to translations for mobile medical apps, we offer translations for the regulations that direct the development, oversight, and sale of these medical apps in global markets, including\u00a0CE <\/u>m<\/u>arking translations<\/u><\/a><\/span>\u00a0and\u00a0MDR translations<\/u><\/a><\/span>\u00a0for EU markets.<\/p>\n Learn more\u00a0about our mobile medical app translations<\/u><\/a><\/span>.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/03\/app.png” alt=”\u533b\u5b66\u8f6f\u4ef6\u7cfb\u7edf\u6307\u5357\u7684\u76d1\u7ba1\u7ffb\u8bd1” title_text=”app” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ width=”79%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2017\/10\/scientist_taking_notes.jpg” parallax=”on” custom_padding=”80px|0px|66.1875px|0px|false|false” locked=”off”][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ text_font_size=”18px” hover_enabled=”0″]<\/p>\n Clinical decision support translations enable clinicians and other healthcare workers to provide the best possible care for patients around the world. Clinical decision support, sometimes called CDS, are tools used to improve point of care decision making, such as medication alerts, risk scores for disease or condition, and computer-aided detection or diagnosis (CADe\/CADx). With the growth of AI and machine learning<\/u><\/a><\/span>\u00a0applications in healthcare, including generative AI like ChatGPT, these systems are even more important to provide up-to-date and efficient care for patients. Importantly, some clinical decision support software may be regulated as medical devices under guidance from the U.S. FDA and other regulatory bodies. Even for Non-Device CDS, accurate medical translation of materials from regulatory experts and software localization by experienced engineers is crucial to ensure only the best care. CSOFT Health Sciences leverages a global team of over 10,000 linguists, subject matter experts, and software engineers to provide clinical decision support translations for healthcare providers across languages.<\/p>\n Learn more about our clinical decision support translations<\/u><\/a><\/span>.[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_enable_color=”off” custom_padding=”0|0px|0px|0px|false|false” locked=”off”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px” border_width_top=”1px” border_color_top=”#cccccc” global_module=”175789″ saved_tabs=”all”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n\n\n\n \u901a\u8fc7\u6211\u4eec\u57fa\u4e8e\u4e91\u7684\u521b\u65b0\u6280\u672f<\/u><\/a><\/span>\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u63d0\u4f9b\u4e86\u4e00\u4e2a\u5728\u7ebf\u7ffb\u8bd1\u7ba1\u7406\u751f\u6001\u7cfb\u7edf\uff0c\u7cfb\u7edf\u4e2d\u5fc3\u4f4d\u7f6e\u5b9e\u65f6\u5229\u7528\u7ffb\u8bd1\u8bb0\u5fc6\u4ee5\u53ca\u672f\u8bed\u7ba1\u7406\u3002<\/p>\n\n \u9ad8\u8d28\u91cf\u7684\u7ffb\u8bd1\u548c\u672c\u5730\u5316\u4e1a\u52a1\u5bf9\u653f\u5e9c\u673a\u6784\u6781\u4e3a\u91cd\u8981 - \u4e0d\u51c6\u786e\u7684\u7ffb\u8bd1\u4e0d\u4ec5\u4f1a\u5bfc\u81f4\u65f6\u95f4\u3001\u6210\u672c\u548c\u7cbe\u529b\u7684\u6d6a\u8d39\uff0c\u800c\u4e14\u8fd8\u4f1a\u5f71\u54cd\u60a3\u8005\u548c\u6d88\u8d39\u8005\u7684\u751f\u6d3b\u3002\u8fd9\u5c31\u662f\u4e3a\u4ec0\u4e48CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u81f4\u529b\u4e8e\u786e\u4fdd\u6700\u9ad8\u8d28\u91cf\u7684\u7ffb\u8bd1\u670d\u52a1\u3002\u4e3a\u6b64\uff0c\u6211\u4eec\u8058\u8bf7\u81f3\u5c11\u67097\u5e74\u7ecf\u9a8c\u7684\u672c\u571f\u8bed\u8a00\u5b66\u5bb6\uff0c\u5e76\u4e14\u4e0d\u65ad\u62d3\u5c55\u6211\u4eec\u7684\u591a\u9886\u57df\u4e3b\u9898\u4e13\u5bb6\u7f51\u7edc\u3002\u6b64\u5916\uff0c\u6211\u4eec\u901a\u8fc7\u8bed\u8a00\u9a8c\u8bc1<\/u><\/a><\/span>\u3001\u56de\u8bd1<\/u><\/a><\/span>\u548c\u672f\u8bed\u7ba1\u7406<\/u><\/a><\/span>\u4e0d\u65ad\u5b8c\u5584\u672c\u5730\u5316\u6700\u4f73\u5b9e\u8df5\uff0c\u5e2e\u52a9\u653f\u5e9c\u673a\u6784\u3001\u975e\u653f\u5e9c\u7ec4\u7ec7\u3001\u516c\u5171\u90e8\u95e8\u548c\u56fd\u9645\u7ec4\u7ec7\u63a5\u89e6\u4e0d\u540c\u6587\u5316\u80cc\u666f\u7684\u793e\u533a\u3002\u4e3a\u4e86\u786e\u4fdd\u9ad8\u8d28\u91cf\u7684\u6280\u672f\u7ffb\u8bd1\u89e3\u51b3\u65b9\u6848\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u7684\u4e13\u4e1a\u6027\u5f97\u5230\u4e86ISO 17100:2015\u3001ISO 9001:2015<\/b><\/strong>\u548cISO 13485:2016<\/b><\/strong>\u8ba4\u8bc1\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u652f\u6301\u3002\u540c\u65f6\uff0c\u6211\u4eec\u7684\u64cd\u4f5c\u6d41\u7a0b\u7b26\u5408ISO 27001<\/b><\/strong>\u7684\u6700\u4f73\u5b9e\u8df5\uff0c\u786e\u4fdd\u6211\u4eec\u7684\u5b9a\u5236\u5316\u89e3\u51b3\u65b9\u6848\u7b26\u5408\u5168\u7403\u76d1\u7ba1\u8981\u6c42\u3002\n<\/p>\nMedical Device\u00a0Translation and\u00a0Localization Solutions<\/h2>\n
Mobile Medical App Translations<\/h2>\n
Clinical Decision Support Translations<\/h2>\n
\u8d28\u91cf\u4fdd\u8bc1<\/h2>\n\n