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前海安测产品获CFDA医疗器械注册证

日期:2019-03-22 来源:易特科 浏览次数190410

喜讯!日前,前海安测正式通过医疗器械质量管理体系(医疗器械GMP)考核,符合医疗器械产品准入规定,并于2019年初顺利取得CFDA医疗器械注册证。


这对前海安测产品研发、生产及市场推广具有里程碑式意义:

1.生产及研发突出优势:

目前与我司产品相似的生产企业有几十家,但真正取得医疗器械认证的企业仅有两家。这充分体现了前海安测医疗器械产品在设计、研发、生产、品保过程中的严谨态度和负责任的精神,更证明了前海安测强大的技术实力和产品优越性;

前海安测获得CFDA认可的产品拥有发明专利,并且获得了国家专利优秀奖,是国家工信部推荐产品。产品采用国际上通行的系统开发模式和先进的系统流程和技术,具有较强的连通性、兼容性和可扩展性,有完整的系统解决方案和数据安全保护等功能特点,适用于医疗机构、社康中心、养老机构、保健部门,适合不同规模不同档次的医院,能满足不同档次医院的不同需求。

2.品牌认可度更高:

获得CFDA认证,证明我司医疗卫生信息化与智能化的软硬件产品有显著的临床应用价值,整体解决方案在技术研发、生产品质保证和政策法规上获得国家认可;在企业招投标、市场销售、品牌推广中更容易获得客户的信任和满意;

3.IPO上市新征程:

前海安测已获得GMP生产规范认证,产品取得医疗器械CFDA注册证,为作为生物科技发行人登录香港主板上市奠定了技术基础。

医疗器械注册,是指依照法定程序,对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价,以决定是否同意其销售、使用。前海安测取得医疗器械CFDA注册证,说明我司研发的产品在安全和有效方面得到了国家的全面认可!

前海安测根据医疗器械GMP的要求,建立了强有力的研发团队,为产品的技术服务提供强大的技术支持;建立了满足GMP要求的生产场地,为产品提供有效的过程品质保证;建立了完备的质量检验机构,为原料、产品提供全面的品质保证;建立了全方位的售后服务部门,为客户提供全方位的售后服务。这充分体现了前海安测将客户需求、前沿技术、医疗体系改革的需要有效地结合一起,为用户提供高质量产品、为客户的健康提供优质保障、为客户满意提供全方位服务。同时,随着集团更多智慧医疗产品上市,也有利于打破进口产品垄断,降低诊疗费用,使患者真正得到实惠。

近年来,集团研发与创新不断取得巨大进展,市场开拓不断突破,重大智慧医疗项目捷报频传!前海安测将严格遵守国家医疗器械质量管理规范,全面贯彻安全、有效、实用、方便、先进的理念,完善研发管理体系,加强医疗器械生产质量管理,严格按医疗器械生产质量管理规范实施各项活动,保证医疗器械安全有效;并进一步提高自主研发的医疗产品的质量控制水平,以此推动前海安测产品研发和质量控制能力再上新台阶,实现产品研发科技化、效率化、前端化、全球化!同时完善售后服务能力。力争为客户提供高品质、高水准、全方位的医疗健康服务,满足人们对健康的新期盼,助力健康中国建设!

Qianhai AnyCheck products obtained CFDA medical device registration certificate

Good news! Recently, Qianhai AnyCheck officially passed the medical device quality management system (medical device GMP) assessment, in line with the medical device product access regulations, and in early 2019, successfully obtained the CFDA medical device registration certificate. This has a milestone significance for the development, production and marketing of Qianhai AnyCheck products:

1. Outstanding advantages in production and R&D:

At present, there are dozens of production companies similar to our products, but only two companies that have obtained medical device certification. This fully demonstrates the rigorous attitude and responsible spirit of Qianhai AnyCheck in the design, research and development, production and quality assurance of medical device products, and proves the strong technical strength and product superiority of Qianhai AnyCheck;

Qianhai AnyCheck has obtained the invention patent for the products recognized by CFDA, and has won the National Patent Excellence Award. It is recommended by the Ministry of Industry and Information Technology. It adopts the internationally popular system development model and advanced system processes and technologies. It has strong connectivity and compatibility. Sexuality and scalability, complete system solutions and data security protection, suitable for medical institutions, social welfare centers, old-age care institutions, health departments, suitable for hospitals of different scales and different grades, can meet different hospitals of different grades demand.

2. Higher brand recognition:

Obtained CFDA certification, which proves that our medical and health information and intelligent software and hardware products have significant clinical application value. We have obtained national research and development, production, sales, implementation and overall solutions in technology research and development, production quality assurance and policies and regulations. Recognition; it is easier to obtain customer trust and satisfaction in corporate bidding, marketing, and brand promotion;

3. IPO listing new journey:

Qianhai AnyCheck has obtained GMP production standard certification, and the product has obtained the CFDA registration certificate for medical equipment, laying a technical foundation for the biotech issuer to log on to the Hong Kong main board.

Medical device registration refers to the systematic evaluation of the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to determine whether or not to approve their sales and use. Qianhai AnyCheck obtained the CFDA registration certificate for medical equipment, indicating that the products developed by our company have been fully recognized by the state in terms of safety and effectiveness!

Qianhai AnyCheck has established a strong R&D team according to the requirements of medical device GMP, providing strong technical support for the technical service of products; establishing a production site that meets GMP requirements, providing effective process quality assurance for products; establishing a complete The quality inspection agency provides comprehensive quality assurance for raw materials and products; establishes a comprehensive after-sales service department to provide customers with comprehensive after-sales service. This fully demonstrates that Qianhai AnyCheck fully integrates the needs of customers, cutting-edge technologies and medical system reforms to provide high-quality products for users' needs, provide high-quality guarantee for customers' health, and provide customers with full satisfaction. Directional service. At the same time, as the Group's more intelligent medical products are listed, it will also help to break the monopoly of imported products, reduce the cost of medical treatment, and make patients truly benefit.

In recent years, the Group's R&D and innovation have made tremendous progress, and the market has made continuous breakthroughs. The major wisdom medical projects have been reported frequently! Qianhai AnyCheck will strictly abide by the national medical device quality management norms, fully implement the concept of safe, effective, practical, convenient and advanced, improve the R&D management system, strengthen the quality management of medical device production, and strictly implement the medical device production quality management standards. Activities to ensure the safety and effectiveness of medical devices; and further improve the quality control level of self-developed medical products, in order to promote the development and quality control capabilities of Qianhai AnyCheck products to a new level, to achieve scientific and technological development, efficiency, front-end, Globalization! At the same time, improve the ability of after-sales service, provide customers with high-quality, high-level, all-round medical and health services, meet people's new expectations for health, and promote healthy China construction.