北京华光泰和医疗技术服务有限公司 - 北京华光泰和医疗技术服务有限公司

企业简介

北京华光泰和医疗技术服务有限公司(简称Medadmt)创建于2015年，是一家专注于医疗器械质量体系、产品注册、法规/标准培训的综合服务提供商，能够为全球客户提供中国医疗器械个性化定制全过程市场准入服务。

Beijing Huaguang Taihe Medical Devices Admittance Technology Service Co., Ltd. (Medadmt for short )was founded in 2015, which is a comprehensive service provider focusing on medical device quality system, product registration, regulations/standards training, and can provide global customers with the whole process of personalized customization of Chinese medical devices market access services.

企业宗旨

华光泰和坚持“专业服务引领健康传递价值”的经营理念，能够为您提供整体医疗器械上市解决方案，已成功的为数百家医疗器械生产企业提供了优质服务，并建立了长期稳定的合作伙伴关系。

Adhering to the business philosophy of "professional service leads health and delivers value", Medadmt can provide you with the overall medical device listing solution, has successfully provided quality services to hundreds of medical device manufacturers, and established long-term stable partnership.

企业优势

公司现拥有超过20多名10年以上医疗器械行业经验的专家团队，凭借卓越的专业知识，通过持续的培训、辅导、行业信息传递和绩效工具来传递知识，帮助客户遵守法规。一旦与您建立合作关系，我们将定期拜访您，以促进公司持续满足法规、标准要求，使您能够更自信的接受行业监管部门以及顾客的定期和不定期考核，在行业内赢得信任。

Medadmt now has a team of more than 20 experts with more than 10 years of experience in the medical device industry, with excellent expertise, through continuous training, coaching, industry information delivery and performance tools to transfer knowledge to help customers comply with regulations. Once we establish a cooperative relationship with you, we will visit you regularly to promote the company to continue to meet the requirements of regulations and standards, so that you can be more confident to accept the regular and irregular assessment of industry regulators and customers, and win trust in the industry.

年

公司创建于

年+

医疗器械经验

名+

专家团队

国内首例

我们为其提供全方位的医疗器械咨询服务，助力其产品从研发到上市的全过程。

We provide them with a full range of medical device consulting services to help their products in the whole process from R&D to market.

术锐机器人-采用世界首创技术的单孔腔镜手术机器人

ShuRui Robot - A single-aperture endoscopic surgical robot using the world's first technology

北京术锐机器人股份有限公司成立于2014年，致力于自主研发、生产和商业化具备全球领先优势的微创腔镜手术机器人系统及配套器械产品，产品搭载面向连续体机构的形变驱控技术，并拥有全链条核心关键技术和完整自主知识产权。设计出搭载超弹性镍钛合金蛇形手术器械的术锐®单孔腔镜手术机器人，继 2020 年成为中国首台通过创新医疗器械特别审查程序的单孔手术机器人之后，于2023 年6 月获得国家药品监督管理局（ NMPA ）的上市批准（注册证号：国械注准 20233010833 ）并于 2024 年2月获得适用范围的变更批准，用于泌尿外科及妇科腹腔镜手术操作，是国内首款能够同时覆盖泌尿外科和妇科腹腔镜手术操作的多科室单孔腔镜手术机器人，有效填补了国内空白。

Beijing ShuRui Robot Co., Ltd. was established in 2014，committed to independent research and development, production and commercialization of minimally invasive endoscopic surgery robot systems and supporting instruments with the world's leading advantages. The products are equipped with deformation drive and control technology for continuum mechanisms, and have the core key technologies of the whole chain and complete independent intellectual property rights. Designed the Shurui ® single-hole endoscopic surgery robot equipped with superelastic Nitinol serpentine surgical instruments. After becoming the first single-hole surgical robot in China to pass the special review procedure for innovative medical devices in 2020, it obtained the marketing approval of the National Medical Products Administration (NMPA) in June 2023 (Registration number: National Medical Device registration approval 20233010833 ),and in February 2024, it was approved to change the scope of application for urology and gynecological laparoscopic surgery. It is the first multi-department single-aperture endoscopic surgery robot that can cover both urology and gynecological laparoscopic surgery at the same time, effectively filling the domestic gap.

安必平-国内首家AI病理诊断与肿瘤筛查

AmBiPing - First AI pathologic diagnosis and tumor screening in China

广州安必平医药科技股份有限公司（股票代码：688393）成立于2005年，是国内病理诊断领域上市企业，集研发、生产、市场、服务、教育五位一体，构建了肿瘤筛查、肿瘤诊断、数智病理、病理服务四大业务，服务全国2200多家医疗机构。

Guangzhou Ambiping Medical Technology Co., LTD. (Stock code: 688393) was established in 2005, is a domestic listed enterprise in the field of pathological diagnosis. It integrates research and development, production, marketing, service and education, and has built four major businesses of tumor screening, tumor diagnosis, digital pathology and pathological service, serving more than 2,200 medical institutions across the country.

安必平专注于肿瘤筛查与精准诊断，围绕医院病理科“自动化、标准化、数字化、智能化”的四化建设，自主开发了液基细胞学（LBC）、免疫组织化学（IHC）、荧光原位杂交（FISH）、数字病理(DP&AI)、聚合酶链式反应（PCR）常规组织病理等技术平台的配套设备、试剂耗材，注册/备案产品数量超800个。

Ambiping focuses on tumor screening and accurate diagnosis, and focuses on the construction of the four modernizations of "automation, standardization, digitalization and intelligence" in the hospital pathology department，have independently developed supporting equipment and reagent consumables for technical platforms such as liquid based cytology (LBC), immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), digital pathology (DP&AI), polymerase chain reaction (PCR) and routine histopathology, and the number of registered/filed products has exceeded 800.

安德医智-国内首家BioMind颅脑肿瘤辅助诊断系统

BioMind-First BioMind craniocerebral tumor auxiliarydiagnosis system in China

北京安德医智科技有限公司专注于医疗领域人工智能应用研发。致力于将AI技术进步服务于人类健康，曾获“工信部新一代人工智能产业创新重点任务入围揭榜单位”“2020年人工智能创新应用优秀案例”等荣誉，被认定为国家高新技术企业和北京市专精特新小巨人企业。公司拥有国际领先的研发团队，团队成员包括来自英国剑桥、美国卡耐基梅隆、清华、北大等世界顶级科研机构的深度学习专家和软件开发人才，涵盖医学、人工智能、理工等专业。公司与多家医疗机构共同合作研发，产品广泛应用于医院神经内外科、介入科、影像科、超声科、急诊等科室，以及医院科研、教学等多种场景，不仅能赋能大型综合医院日常医疗和质控工作，还能为广大基层医疗机构提升医疗水平提供强有力的支持。

Beijing BioMind Technology Co., Ltd. focuses on the research and development of artificial intelligence applications in the medical field. Committed to the advancement of AI technology to serve human health, has won the "Ministry of Industry and Information Technology of the new generation of artificial intelligence industry innovation key task shortlisted unit", "2020 artificial intelligence innovation application excellent case" and other honors, was identified as a national high-tech enterprise and Beijing specialized special new small giant enterprise. The company has an internationally leading research and development team, including deep learning experts and software development talents from the world's top scientific research institutions such as Cambridge in the UK, Carnegie Mellon in the United States, Tsinghua University, Peking University, etc., covering medicine, artificial intelligence, science and technology. The company has cooperated with a number of medical institutions to research and develop, and the products are widely used in hospital neurology and surgery, interventional department, imaging department, ultrasound department, emergency department and other departments, as well as hospital scientific research, teaching and other scenes, not only to enable the daily medical care and quality control work of large general hospitals, but also to provide strong support for the majority of primary medical institutions to improve the medical level.

合作伙伴

爱博诺德
爱慕股份
安德医智
安启信
澳尔华泰
邦维新材
安必平
宝丰能源
春立正达
航天长峰
华熙生物
科腾生物
联影医疗
术锐
天思英弘
中红医疗
忠冠口腔

公司团队

公司服务团队深入研究、总结法规及标准的变化发展趋势，不断优化调整服务方式和工作方法，我们不仅仅依据法规、标准要求来为您服务，我们还将帮助您达到法规、标准的要求。我们将在您获得产品上市许可过程中提供全程服务来支持您。

Medadmt 's service team has studied and summarized the changes and development trends of regulations and standards, and constantly optimized and adjusted service methods and working methods. We not only serve you according to regulations and standards, but also help you meet the requirements of regulations and standards. We will support you throughout the process of obtaining marketing approval for your products.

陈建军
张兵
米兰英
李文翠
刘霞
陈艳蕊
王明风

陈建军 Chen Jianjun 总经理 General manager

◆ 中国科技经营管理大学

China University of Science and Technology Business management

本科Undergraduate course

◆ 应用电子技术

Application of electronic technology

◆ 国家注册审核员，资深法规、注册、标准顾问；资深法规、内审员、注册、体系审核专业讲师；

National Certified auditor, Senior regulatory, registration, standards consultant; Senior regulation, internal auditor, registration, system audit professional lecturer;

◆ 北京国医械华光认证有限公司专职审核员7年，兼职审核员6年；

Beijing Hua Guang Certification of Medical Devices Co.,Ltd.. full-time auditor for 7 years, part-time auditor for 6 years

◆ 北京国医械华光认证有限公司体系、法规讲师，有源、无源、无菌、植入、IVD产品资深咨询老师；

Beijing Hua Guang Certification of Medical Devices Co.,Ltd. System, regulation lecturer, active, passive, sterile, implant, IVD products senior consulting teacher;

◆ 医疗器械行业经验20年，曾担任国内三类有源、无菌、IVD医疗器械产品生产企业质量总监和运行总监；具有丰富法规、理论与实际相结合的实践经验，能将日常管理运用到教学过程中。

20 years of experience in the medical device industry, served as the quality director and operation director of Class III of active, sterile, IVD medical device product manufacturers in China, has rich practical experience in combining laws and regulations, theory and practice, able to apply daily management to the teaching process

审核企业约500家，咨询医疗器械企业约200家，其中欧盟MDD/MDR体系，FDA/QSR820体系10余家。

Audited about 500 companies, and consulted about 200 medical device companies, including more than 10 EU MDD/MDR systems and FDA/QSR820 systems.