[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ custom_margin=”|||” custom_padding=”0px|0px|0px|0px”][et_pb_fullwidth_header button_one_text=”Treten Sie jetzt mit uns in Kontakt” button_one_url=”https:\/\/lifesciences.csoftintl.com\/de\/kontakt\/” background_overlay_color=”rgba(0,0,0,0)” content_max_width=”68%” content_max_width_tablet=”” content_max_width_phone=”” content_max_width_last_edited=”on|desktop” module_class=”hide-h1″ _builder_version=”4.5.3″ content_font_size=”22px” content_line_height=”1.6em” background_color=”rgba(255,255,255,0)” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/10\/medical-devices-translation.jpg” parallax=”on” parallax_method=”on” custom_button_two=”on” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”60px||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 provide the highest-quality medical device translations and localization solutions for life science companies expanding into international markets[\/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=”|||”][divienhancer_breadcrumb _builder_version=”3.20.2″][\/divienhancer_breadcrumb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ parallax=”on” custom_padding=”0px||”][et_pb_row make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”||0px”][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”]<\/p>\n
The medical device sector (a part of the medical technology, or Medtech, industry) focuses on medical technology:\u00a0machines, devices, and apparatuses that treat, diagnose, and prevent diseases. Because of this crucial function,\u00a0medical device translations\u00a0are essential for reaching new patients and global markets.<\/p>\n
Gaining the competitive advantage in a global industry currently valued at over\u00a0400 billion USD means that each step of the device\u2019s lifecycle, from R&D and manufacturing to regulation and oversight, requires detailed documentation that may be specific to certain markets. To gain regulatory approval, effectively compete in overseas markets, and ensure\u00a0patient safety,\u00a0medical device documentation such as\u00a0instructions for use (IFU)<\/u><\/a><\/span>\u00a0and\u00a0package inserts and labels<\/u><\/a><\/span>\u00a0must be translated accurately and with fast turnaround times. With a global network of 10,000+\u00a0in-country linguists and subject matter experts, CSOFT\u00a0Health Sciences provides\u00a0medical device\u00a0manufacturers with highly accurate and timely medical device translation services\u00a0in 250+ languages, including all kinds\u00a0of\u00a0medical document translations<\/u><\/a><\/span>,\u00a0medical software translation and localization<\/u><\/a><\/span>, and\u00a0medical eLearning\u00a0and training\u00a0translations<\/u><\/a><\/span>.<\/p>\n CSOFT Health Sciences offers\u00a0translation and localization solutions for a full range of medical devices, including:[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”||0px”][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_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Medical-Device-2.jpg” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”80%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][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 disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#eef8fb” parallax=”on” custom_padding=”20px||20px”][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_font_size=”16px”]<\/p>\n In May 2021, the European Union\u2019s Medical Device Directive (MDD) (93\/42\/EEC) and Directive on Active Implantable Medical Devices (90\/385\/EEC) was replaced,\u00a0and\u00a0medical devices are now\u00a0fully covered by the Medical Device Regulation (MDR). The MDR brings many new changes\u00a0for manufacturers, including changes to medical device labelling and language requirements\u00a0to gain EU MDR compliance. This has\u00a0created\u00a0new\u00a0challenges\u00a0for medical device manufacturers attempting to gain market access to EU\u2019s diverse market. With all these new changes, it\u00a0is important for medical device manufacturers to establish a partnership with a language service provider (LSP) that has an in-depth understanding of the new EU MDR\u00a0and its implementation,\u00a0to ensure there are no delays for medical device products entering EU\u2019s market.\u00a0With proven experience working with the medical device industry\u00a0around the globe, CSOFT Health Sciences provides\u00a0MDR\u00a0regulatory translations to help companies meet the EU\u2019s standards for bringing\u00a0medical devices to market.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our EU Medical Device Regulation (MDR) translations.<\/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\/2021\/02\/mdr-img-1.jpg” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”80%” 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_color=”#f9f9f9″ background_position=”center_right” custom_padding=”30px|0px|30px|0px|false|false” locked=”off”][et_pb_row make_equal=”on” _builder_version=”4.5.3″ background_color=”rgba(255,255,255,0)” background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”20px||20px||false|false” border_radii=”on|5px|5px|5px|5px” border_color_bottom=”#cccccc”][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 _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”18px” text_orientation=”center” custom_margin=”||29px|5px”]<\/p>\n In the medical field, software has a growing place in accelerating the 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. SaMD is any software that carries out medical functions without the need of actual hardware, and can help patients and healthcare providers in diagnosing and screening for disease, monitoring and alerting around chronic health conditions, disease and condition management, and digital therapeutics.<\/p>\n As a relatively new field within healthcare, SaMD plays a specific role, for example as the software used to control the motors of an infusion pump or the software that enables medical communications, including video calling, scheduling appointments, and digital patient registration. More broadly, the applications of SaMD platforms include. As 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 Software as a Medical Device (SaMD) translations in over 250 languages.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our SaMD translations.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ parallax=”on”][et_pb_row column_structure=”1_3,2_3″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][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\/2020\/10\/medical-device1.png” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”80%”][\/et_pb_image][\/et_pb_column][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_font_size=”16px”]<\/p>\n The medical devices\u00a0development process requires medical device manufacturers to submit a variety of medical device documents including\u00a0documents for regulatory\u00a0submissions<\/u><\/a><\/span>,\u00a0\u00a0patents and international business agreements<\/u><\/a><\/span>,\u00a0instructions for use (IFU)<\/u><\/a><\/span>, manufacturing process descriptions,\u00a0package inserts and labels<\/u><\/a><\/span>,\u00a0phase 0-IV clinical trial documentation<\/u><\/a><\/span>,\u00a0post-market safety reporting,\u00a0CE marking technical files<\/u><\/a><\/span>, \u00a0operation procedures, and more. As the demand for medical devices shifts overseas, manufacturers must ensure that\u00a0translations\u00a0of\u00a0each\u00a0medical device\u2019s\u00a0documentation are completed accurately and\u00a0in a timely manner. CSOFT Health Sciences specializes in end-to-end translations\u00a0for\u00a0medical device\u00a0documentation across all stages of the medical device development lifecycle.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our medical\u00a0device\u00a0document translation services.[\/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\/2021\/02\/medical-meeting.jpg” parallax=”on” locked=”off”][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 system guidance translations are imperative to ensuring the success and regulatory compliance of medical software products and services in overseas markets.\u00a0Product-specific guidance\u00a0statements are issued by regulatory bodies such as the US Food and Drug Administration (FDA) and\u00a0describe each agency\u2019s current thinking on how to safely and effectively develop new software products, therapies, or devices. Medical software systems play\u00a0a crucial role in healthcare today and providing the correct documentation in\u00a0the\u00a0languages required for regulatory approval, including\u00a0for limited English\u00a0proficiency\u00a0(LEP) patients in the US, and many languages in the EMA, NMPA, and more,\u00a0is critical for patients and healthcare systems globally. CSOFT Health Sciences specializes in high quality translations for medical software system guidance\u00a0in 250+ languages.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our medical software system guidance translations.<\/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” locked=”off”][et_pb_row _builder_version=”4.5.3″ _module_preset=”default”][et_pb_column type=”4_4″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default” text_orientation=”center”]<\/p>\n Safely and properly operating medical devices to deliver precision care requires an in-depth understanding of the different components, operating systems, and mechanical features of these devices. Medical device manuals are technical documents that\u00a0outline the procedures, instructions, protocols, and schematics pertaining to all types of medical devices. Especially when selling medical devices to international markets or training new staff on how to operate these devices, it is essential that all personnel fully understand the manual without language functioning as a barrier to communication. Whether translating manuals to gain regulatory compliance or to educate staff and suppliers on operational procedures, CSOFT Health Sciences provides end-to-end\u00a0medical device manual translations in 250+ languages.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our medical device manual translations.<\/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″ parallax=”on” locked=”off”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||0px||false|false”][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”]<\/p>\n As the medical devices and medical software markets continue to grow, mobile medical application translations enable companies to expand their operations globally and reach new markets. Mobile applications are becoming an increasingly central feature in most industries, and the use of this technology in the medical field is opening new and innovative opportunities to improve health\u00a0by accurately recording\u00a0patient health\u00a0data. Through mobile medical applications, patients are able to monitor\u00a0their\u00a0health data and gather health metrics in real-time, which has opened the door to a growing demand for localizing these platforms\u00a0and translating content. To help medical application developers tailor their technology to new patients across a\u00a0wide range of languages,\u00a0CSOFT Health Sciences provides end-to-end translations\u00a0for mobile medical applications.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our mobile medical application translations.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/03\/app.svg” title_text=”app” _builder_version=”4.5.3″ _module_preset=”default”][\/et_pb_image][\/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_enable_color=”off” parallax=”on”][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” module_class=”white bg-link” _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_css_before__hover_enabled=”on”][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 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” text_text_color__hover_enabled=”on”]<\/p>\n Software is a core component of many medical devices, with such\u00a0technology\u00a0as X-Rays, CT scans, and\u00a0point-of-care (POC) in<\/u>\u00a0<\/u>vitro diagnostic<\/u>s<\/u>\u00a0<\/u>devices (IVD)<\/u><\/a><\/span>\u00a0transforming our ability to deliver precision care.\u00a0Beyond the software in physical medical devices,\u00a0in the past decade\u00a0there has been a prominent type of medical device called\u00a0Software as a Medical Device (SaMD).\u00a0SaMD refers\u00a0to software that performs medical functions itself, such as enabling\u00a0patients to use their phones to look at MRI scans\u00a0and\u00a0patient portals<\/u><\/a><\/span>\u00a0that offer round-the-clock access to a patient\u2019s health records. To gain regulatory compliance and stay\u00a0competitive in overseas markets, medical device manufacturers must ensure accurate translation and localization of all\u00a0software components. CSOFT Health Sciences has extensive experience in translating software GUI through our localization best practices. Our subject matter experts work closely with our in-country linguists and engineer teams to translate\u00a0all medical device software applications for medical device companies\u00a0across 250+ languages.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our\u00a0\u00a0software translation and localization services.<\/p>\n [\/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_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/12\/software-1.png” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”80%”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_color=”#ffffff” custom_padding=”35px|0px|30px|0px|false|false”][et_pb_row column_structure=”1_3,2_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/10\/eling.png” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”3.23″][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” module_class=”check-list-box” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_3_text_align=”center”]<\/p>\n Medical device manufacturers must ensure that proper training is offered to end-users such as patients, physicians,\u00a0and other healthcare professionals on correct use of medical devices. In addition, medical device manufacturers need to train workers on how to correctly assemble and manufacture medical devices. As the demand for medical devices grows overseas, providing highly accurate and culturally appropriate\u00a0translated\u00a0eLearning and training materials is essential for regulatory compliance and quality assurance. CSOFT Health Sciences provides eLearning\u00a0and training\u00a0translation and localization solutions to maximize product reach and ensure safe medical device operation across multiple markets. In addition, CSOFT offers\u00a0video translation services<\/u><\/a><\/span>\u00a0such as\u00a0multilingual video voiceover<\/u><\/a><\/span>, subtitling, and dubbing.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our eLearning translations and training localization.<\/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_position=”center_right” custom_padding=”0px|0px|0px|0px|false|false” locked=”off”][et_pb_row column_structure=”2_3,1_3″ make_equal=”on” _builder_version=”3.25″ background_color=”rgba(255,255,255,0)” background_size=”initial” background_position=”top_left” background_repeat=”repeat” border_radii=”on|5px|5px|5px|5px”][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 _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”18px” custom_margin=”||29px|5px”]<\/p>\n Regulation and legislation translations are implemented to ensure compliance and to provide safe and high-quality services to clients. Compliance has become more complex due to globalization, heightened expectations, innovation, and ever-evolving customer needs. Whether you are a pharmaceutical company, medical device company, or regulatory body such as the US Food and Drug Administration (FDA), International Organization for Standardization (ISO), or European Union (EU), regulations and legislations ensure safety of product use such as drugs, vaccines, biological medical products, medical devices, and radiation-emitting products. As companies and organizations continue to release products into new markets and reach customers throughout the world, keeping up with regulations and legislations is necessary to meet customer needs. CSOFT Health Sciences provides accurate translations for all types of regulations and legislations. With a global network of in-country linguists and expertise to translate over 250 languages, we localize your regulations and legislation content.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our regulation and legislation translations.<\/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\/05\/regulation-2.png” alt=”Pharmaceuticals require expert translations” title_text=”regulation-2″ align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”80%” 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_color=”#ffffff” custom_padding=”35px|0px|30px|0px|false|false”][et_pb_row column_structure=”1_3,2_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/10\/diagnostic-radiology-translations-1.png” title_text=”diagnostic-radiology-translations-1″ align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” module_class=”check-list-box” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_3_text_align=”center”]<\/p>\n Diagnostic radiology, including the physicians,\u00a0nurses, and\u00a0technicians\u00a0responsible for delivering medical imaging services,\u00a0often works\u00a0with high volumes of clinical content, ranging from\u00a0patient medical records<\/u><\/a><\/span>\u00a0to\u00a0medical device manuals<\/u><\/a><\/span>\u00a0and\u00a0e-Learning services<\/u><\/a><\/span>, all of which need to be localized for international markets. Whether you are a hospital that provides radiology services or a manufacturer responsible for radiology R&D, CSOFT Health Sciences offers the highest quality medical translations for diagnostic radiology in more than 250 languages.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our diagnostic radiology translations.<\/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\/2020\/11\/medical-devices-translation.jpg” custom_padding=”20px|0px|60px|0px|false|false” locked=”off”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”||0px”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” module_class=”bg-link” _builder_version=”4.5.3″ text_font=”||||||||” text_text_color=”#ffffff” text_font_size=”16px” header_font=”||||||||” header_2_font=”||||||||” header_2_text_align=”left” header_2_text_color=”#ffffff” header_3_text_align=”center”]<\/p>\n The medical device sector remains one of the most highly regulated\u00a0industries\u00a0within the life sciences, with strict laws and guidelines in place\u00a0to protect patients, manufacturers, and all end-users of this technology. To navigate these regulations and successfully expand into new global markets, medical device regulatory translations for all required documentation\u00a0are necessary\u00a0and remain an effective solution for adhering to international medical and safety regulations. To help companies safely meet global standards for all phases of the product life cycle,\u00a0CSOFT\u00a0Health Sciences\u00a0provides high quality life science regulatory translations in 250+ languages including medical device\u00a0regulatory translations.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our life science regulatory translations.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ parallax=”on” custom_padding=”60px|0px|60px|0px|false|false” locked=”off”][et_pb_row make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”0|0px|0px|0px|false|false” column_structure=”1_3,2_3″][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\/2023\/03\/medical-wearables-translation3.png” _builder_version=”4.5.3″ _module_preset=”default” title_text=”medical-wearables-translation3″ hover_enabled=”0″ width=”78%”][\/et_pb_image][\/et_pb_column][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_font_size=”16px” custom_margin=”||20px|” hover_enabled=”0″]<\/p>\n Medical wearables translations are essential for medical device companies launching wearable medical devices to patients around the world. Medical wearables are medical devices that are worn on a patient\u2019s body to track vital signs to provide in-time monitoring of medical conditions and even notify patients and their healthcare teams about risks. Just as fitness trackers have taken over the commercial fitness world, wearable health technology and medical monitoring devices are expected to help revolutionize data tracking for healthcare workers and their patients. Medical wearables use advanced medical technology including ECG and blood pressure monitors, biosensors, and fall detection.<\/p>\n Whether medical wearables are used in decentralized clinical trials to monitor patient outcomes, to help patients recover after surgery and into rehabilitation programs, or to improve outcomes in hospitals, medical wearable translations ensure that these advances are accessible for every patient. From software localization<\/u><\/a><\/span>\u00a0and good manufacturing practice (GCP)<\/u><\/a><\/span>\u00a0to multilingual patents<\/u><\/a><\/span>, our experts help companies advance health for the highest ROI. CSOFT Health Sciences\u2019 global team of 10,000 in-country linguists, subject matter experts and software engineers is experienced in providing accurate and efficient translations for medical wearables and other medical devices.<\/p>\n Learn more about our medical wearables translation<\/u><\/a><\/span>.[\/et_pb_text][\/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”]\n\n\n \nCSOFT Health Sciences has\u00a0developed a process for quality assurance to ensure that every medical translation\u00a0project meets quality standards in a cost-effective and timely manner. We are certified in\u00a0ISO 17100:2015<\/b><\/strong>,\u00a0ISO 9001:2015<\/b><\/strong>, and\u00a0ISO 13485:2016<\/b><\/strong>\u00a0<\/b><\/strong>to ensure our customized solutions meet global regulatory requirements. Our\u00a0subject matter expert linguists have a minimum of 7 years\u2019 experience and work with in-country reviewers and project style guides to meet industry standards.\u00a0And\u00a0through our\u00a0innovative cloud-based technology<\/u><\/a><\/span>, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.\u00a0Every step of the way, CSOFT has you covered.\n\n<\/p>\n\n
EU MDR Translations<\/h2>\n
Software as a Medical Device (SaMD) Translations<\/h2>\n
Medical Device Document Translations<\/h2>\n
Medical Software System Guidance Translations<\/h2>\n
Medical Device Manual Translations<\/h2>\n
Mobile Medical Application Translations<\/h2>\n
Medical Device Software Translation and Localization<\/h2>\n
eLearning\u00a0and Training Translations<\/h2>\n
Regulation and Legislation Translations<\/h2>\n
Diagnostic Radiology Translations<\/h2>\n
Medical Device Regulatory Translations<\/h2>\n
Medical Wearables Translation<\/h2>\n
Quality Assurance<\/h2>\n