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祝贺前海安测通过GMP国家认证

日期:2019-01-07 来源:易特科 浏览次数190229

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质量管理体系(医疗器械GMP)考核。本次考核,充分体现了前海安测建设安全有效的产品质量保证体系信心与决心。考核的顺利通过,说明易特科(前海安测)在建设质量管理体系中取得较好的成绩,得到了监管机构的充分认可。


易特科(前海安测)自成立之初就遵守国家医疗器械质量管理制度,坚持“诚信服务,追求客户满意;不断创新,树立行业品牌”的方针,严格审核与产品功能、特性相关的安全性和有效性的质量细节,建立包括产品开发到交付过程全生命周期的质量监督的一套完整、有效的质量管理体系,从根本上杜绝质量漏洞,保证交付到客户朋友手中的产品的高质量。未来,易特科(前海安测)将强化健全目标管理制度,完善产品质量安全可追溯性体系,以法规标准要求为基础,以产品的风险管理为导向,以满足客户的需求为目标,不断提升集团全体员工的质量意识,维护品牌信誉,提高社会效益和经济效益!

易特科集团品质管理部总监梁艳妮女士表示,易特科(前海安测)下一步计划就是进一步提高自主研发的医疗产品的质量控制水平,并以此推动易特科(前海安测)产品质量控制能力再上新台阶。公司在日常工作中将加强产品品质监控、生产过程过程检查,督促员工认真细致做好每一项生产工作,并在生产过程中严格执行质标准化作业,确保生产出高质量产品,同时完善售后服务的能力,为客户提供高品质、高水准、全方位的医疗服务,帮助社会实现更健康、更长寿和更完美幸福生活的追求!

易特科集团(前海安测)是一家专业从事生命IT技术研究和产品开发的高新技术企业。2003年创立以来,易特科深耕医疗大健康行业,以尖端技术研究和创新为公司核心发展战略,注重企业文化和品牌建设,持续投入信息技术、生物科技、数字技术等领域,以最先进的人工智能、大数据、深度学习等技术和产品服务于医疗信息化、健康养老行业。

易特科集团总部位于深圳南山科技园数字技术园,在北京、上海、广州、天津、西安、石家庄、福州、沈阳、长沙、桂林、香港等地设有分部,并在美国硅谷、欧洲爱尔兰和芬兰和中国香港等地设有海外分支机构。目前,医疗智能化、智能检测设备、医疗信息化、健康信息化、区域卫生信息化等产品和解决方案入选国家工信部产品服务推广目录,并广泛应用于全国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。

多年来,易特科一直秉承“创新驱动·技术引领”的经营理念,与国内外众多知名高校、研究机构和科学家团队建立了广泛的合作关系,在智慧医疗和健康养老领域持续创新和产业化应用。目前,拥有院士工作站、博士后工作站、博士工作站;核心科学家包括诺奖科学家2名、中外院士5名、教授10名、博士28名和研发人员200余名。

目前,易特科在“AI+医疗+健康+养老”领域已申请/拥有各类知识产权3000多项,是国家、广东省和深圳市知识产权优势企业、广东省知识产权示范企业,并获得了四项中国专利优秀奖,在智慧医疗细分领域专利申请数量国内第一、世界第四,四家子公司入选2018中国企业PCT国际专利申请排行榜TOP100;已获得ISO9001质量体系认证、美国软件工程学会CMMI3认证、信息系统集成及服务企业三级资质;是国家级智慧健康养老应用试点示范企业、国家工信息部医疗大数据产业发展试点示范企业,广东省健康管理互联网工程技术研究中心、广东省慢性病大数据工程技术研究中心和广东省医疗大数据示范基地;并获得中国互联网+医疗健康领军品牌、中国互联网+医疗健康最佳解决方案、中国智慧医疗行业领军企业、中国智慧医疗行业重质量、守诚信示范企业奖等荣誉。另外,国家各级主管部门授予易特科2018年广东省高成长中小企业、深圳市便利直通车服务企业、南山区绿色通道企业。

此外,凭借在生命IT、大健康和互联网医疗领域的杰出贡献,易特科集团董事长兼CEO张贯京先生获评2018中国智慧医疗行业领军人物、中国智慧医疗行业诚信企业家功勋奖、广东省特支计划科技创业领军人才等荣誉。

未来,易特科将以持续的创新能力、深厚的技术积累和优质的客户服务,打造“独角兽”硬科技高新技术企业,快速迈进IPO。

Recently, E-Techco (Qianhai AnyCheck) learned from the official website that Shenzhen Qianhai AnyCheck Information Technology Co., Ltd. successfully passed the medical device quality management system (medical device GMP) assessment. This assessment fully demonstrates the confidence and determination of Qianhai AnyCheck to build a safe and effective product quality assurance system. The successful passing of the assessment shows that E-Techco (Qianhai AnyCheck) has achieved good results in the construction quality management system and has been fully recognized by the regulatory authorities.

Since its establishment, E-Techco (Qianhai AnyCheck) has adhered to the national medical device quality management system and adhered to the principle of “integrity service, pursuit of customer satisfaction, continuous innovation, and establishment of industry brand”, and strictly audited safety related to product functions and features. Quality and effectiveness of quality details, establish a complete and effective quality management system including quality supervision from product development to delivery process life cycle, fundamentally eliminate quality loopholes and ensure the high quality of products delivered to customers and friends . In the future, E-Techco (Qianhai AnyCheck) will strengthen the sound target management system, improve the product quality and safety traceability system, based on the requirements of laws and regulations, and take the risk management of products as the guide to meet the needs of customers. Improve the quality awareness of all employees of the Group, maintain brand reputation, and improve social and economic benefits.

AI R&D engineers at the production site

Ms. Liang Yanni, Director of Quality Management Department of E-Techco Group, said that the next step of E-Techco (Qianhai AnyCheck) is to further improve the quality control level of self-developed medical products, and to promote the quality of E-Techco (Qianhai AnyCheck) products. Control capacity has reached a new level. In the daily work, the company will strengthen product quality monitoring, production process inspection, and urge employees to carefully and carefully do each production work, and strictly implement quality standardization operations in the production process to ensure the production of high-quality products, while improving after-sales service. The ability to provide customers with high-quality, high-level, all-round medical services to help the society achieve a healthier, longer life and more perfect life pursuit.

E-Techco Group (Qianhai AnyCheck) is a high-tech enterprise in life IT technology research and product development. Since its establishment in 2003, E-Techco has been deeply rooted in the medical health industry, with cutting-edge technology research and innovation as its core development strategy, focusing on corporate culture and brand building, and continuing to invest in information technology, biotechnology, digital technology and other fields. It uses the most advanced AI, big data, deep learning and other technologies and products to serve medical informationization and health care industry.

E-Techco Group is located in Shenzhen Nanshan S&T Park Digital Technology Park, with branches in Beijing, Shanghai, Guangzhou, Tianjin, Xi'an, Shijiazhuang, Fuzhou, Shenyang, Changsha and Guilin. And overseas branches are in Hong Kong, Silicon Valley, Europe, Ireland and Finland, etc. At present, products and solutions of company such as medical intelligence, intelligent testing equipment, medical informationatization, health informationatization, and regional health informationatization have been selected into the catalogue of promoted product from the Ministry of Industry and Information Technology of China, and are widely used in more than 650 top three hospitals, 450 social health centers and health management centers. The products have received positive response and wide acclaim from the market.

Over the years, E-Techco has been adhering to the business philosophy of “Innovation-driven and technology-led”, and has established extensive cooperative relationships with many well-known universities, research institutes and scientists at home and abroad, and continues to innovate and industrialize in the fields of smart medical care and healthy retirement. application. At present, there are academician workstations, postdoctoral workstations, and doctoral workstations; core scientists include 2 Nobel Prize scientists, 5 Chinese and foreign academicians, 10 professors, 28 doctors, and more than 200 research and development personnel.

At present, E-Techco has applied/owned over 3,000 kinds of intellectual property rights in the field of “AI+ Medical+ Health+ Elderly Care”. It has honored Intellectual Property Advantage Enterprise of China, Guangdong Province and Shenzhen. It also has achieved demonstration enterprise of intellectual property rights of Guangdong Province. Besides, it achieved four China Patent Excellence Awards, and the number of patent applications in the field of smart medical segment ranked first in the country and fourth in the world. Four subsidiaries of group are selected as TOP100 in the PCT international patent application list of 2018 Chinese enterprises. It has obtained ISO9001 quality system certification and US software engineering CMMI3 certification, information system integration and service enterprise three-level qualification. It is a national-level smart health elderly care application pilot model enterprise, the National Ministry of Industry and Information Technology medical big data industry development pilot model enterprise, Guangdong Province Health Management Internet Engineering Technology Research Center, Guangdong Province Chronic Disease Big Data Engineering Technology Research Center and Guangdong Medical Data Demonstration Base and won the Chinese Internet + medical health leading brand, China Internet + medical health best solution, China's smart medical industry leader, China's smart medical industry, quality, Honor in honor of the Demonstration Enterprise Award. In addition, the competent authorities at all levels of the state granted E-Techco's 2018 Guangdong high-growth SMEs, Shenzhen's convenient through-train service enterprises, and Nanshan District Green Passage Enterprise.

In addition, with outstanding contributions in life IT, health and Internet medical, Mr. Zhang Guanjing, Chairman and CEO of E-Techco Group, was awarded the 2018 China Smart Healthcare Industry Leader, China Smart Healthcare Industry Honest Entrepreneur Meritorious Award, Guangdong Province Special Honoring the talents of planning, technology, entrepreneurship and leading talents.

In the future, E-Techco will build an “unicorn” hard technology high-tech enterprise with continuous innovation capability, deep technical accumulation and high-quality customer service, and is preparing for the process of IPO.