前海安测获颁国家三类医疗器械经营许可证

2019-07-12 16:41


根据相关部门官网信息,深圳市前海安测信息技术有限公司顺利通过《医疗器械经营质量管理规范》(经营GSP),于近期取得三类医疗器械经营许可证。这是继前期通过《医疗器械生产质量管理体系》(医疗器械GMP)考核后的又一项突破,充分说明了前海安测在建设质量管理体系中再一次得到了监管机构的认可和支持,为今后开拓更广阔的医疗健康市场、早日IPO上市奠定了良好的基础。


前海安测是一家集产品研发、生产、销售、经营为一体的高新科技企业,产品研发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。目前,前海安测获得的国际认证有:医疗器械生产质量管理规范、医疗器械经营质量管理规范、ISO 9001质量管理体系认证、ISO 20000信息技术服务管理体系认证、ISO 27001 信息安全管理体系认证、GB/T29490知识产权管理体系认证、CMMI3认证、信息系统集成及服务资质三级认证。

前海安测经营的医疗智能化、医疗信息化、健康信息化、区域卫生信息化、智能检测设备等五大创新产品模块,广泛应用于全国650多家三甲医院、二甲医院以及450家社康中心和健康管理中心,得到了市场的积极响应和广泛好评。前海安测旗下安测健康智能一体机等产品荣获4项中国专利奖;AI慢病管理系统荣获科技进步二等奖;旗下产品安测自助健康监测智能一体机和安测慢性病管理平台服务入选国家工信部、国家民政部、国家卫健委联合推荐的《智慧健康养老产品及服务推广目录》; “医疗大数据研究和个性化健康服务应用示范项目”入选国家工信部2018医疗大数据产业示范项目。

同时,前海安测在生产过程中坚持全过程质量管理,公司设置专职检验员和品质管理部门,在设计-采购-生产-销售-使用-服务全过程实行品质管理;产品经营过程中严格执行首营准入、采购、验收、仓储、运输、售后服务等流程;始终坚持做到客户投诉率≤1%、顾客满意度>90分。今后,我们还将以最诚挚的态度、最诚信的服务为客户提供最满意的产品和服务,为实现健康中国梦作出更大的贡献!

Qianhai AnyCheck has awarded the national permit for operation of the Third Type Medical Device

According to the official website information of relevant departments, Shenzhen Qianhai AnyCheck Information Technology Co., Ltd. have recently obtained the national permit for operation of the Third Type Medical Device. By consequently obtaining “Medical Device Production Quality Management System” (Medical Device GMP) and “Medical Device Management Quality Management Regulations” (Medical Device Management GSP), Qianhai AnyCheck prove itself in construction Quality management systems, which have been once again admitted and supported by regulatory Authorities, and have built a good foundation for Qianhai AnyCheck to develop a broader medical and health market, as well as early IPO listing.

Qianhai AnyCheck is a high-tech enterprise integrating product development, production, sales and operation. The product development adopts the internationally popular system development models and advanced system processes and technologies. Our products have strong connectivity, compatibility and scalability, have complete system solutions and data security protection features, suitable for medical institutions, social welfare centers, old-age care institutions, health departments, suitable for hospitals of different scales and grades, can meet the different needs of different grades of hospitals. At present, the international certifications obtained by Qianhai AnyCheck includes: Medical Device Production Quality Management Specifications, Medical Device Management Quality Management Standards, ISO 9001 Quality Management System Certification, ISO 20000 Information Technology Service Management System Certification, ISO 27001 Information Security Management System Certification, GB /T29490 Intellectual Property Management System Certification, CMMI3 Certification, Information System Integration and Service Qualification Level III Certification.

The five innovative product modules of Qianhai AnyCheck, such as medical Intelligent, medical Informatization, health Informatization, regional health Informatization, and intelligent testing equipments, are widely used in more than 650 third-grade/second-grade class-A hospitals, and 450 social rehabilitation centers and health management centers in China, receiving positive response and widely favorable comments.

Qianhai AnyCheck's products, such as AnyCheck Health and Intelligent All-in-One, won four Chinese Patent Awards; AI Chronic Disease Management System won the Second Prize For Scientific And Technological Progress; Anycheck self-service health monitoring intelligent All-in-One and Anycheck chronic disease management platform service were elected in “Smart Health and Endowment Products and Services Promotion Catalogue” jointly recommended by the Ministry of Industry and Information Technology, the Ministry of Civil Affairs and the National Health and Health Commission; the “Medical Big Data Research and Personalized Health Service Application Demonstration Project” was selected as the National Ministry of Industry and Information Technology 2018 Medical Big Data Industry Demonstration Project.

Meanwhile, Qianhai Anycheck adheres to the whole process quality management in the production processes. The company sets up full-time inspectors and quality management departments to implement quality management in the whole process of design-procurement-production-sale-use-service; In the course of product operation, the first-step access, procurement, acceptance, warehousing, transportation, after-sales service and other processes are strictly implemented; insisting that the customer complaint rate is always ≤1%, and customer satisfaction is >90 points. In the future, we will provide customers with the most satisfactory products and services with the most sincere attitude and the most sincere services, as as to promote the implementation of the Healthy China Strategy.