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BEIJING, Dec. 15, 2023 /PRNewswire/ -- Recently, Wandong's seven major series of products obtained the MDR certificate, following the completion of the first MDR certification for superconducting magnetic resonance.So far, Wandong's full range of X-ray, CT and MRI products have been completed the switching from CE MDD to CE MDR..
北京,2023年12月15日/PRNewswire/——最近,继完成第一个超导磁共振MDR认证后,万东的七大系列产品获得了MDR证书。到目前为止,万东的全系列X射线、CT和MRI产品已经完成了从CE MDD到CE MDR的转换。。
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High standards define high reliability
高标准定义高可靠性
CE certification, as a 'visa' for products to enter the European market, is a mandatory requirement for product access in the EU market. The Medical Device (MDR) Regulation (EU) 2017/745 was issued in May 2017, compared with the MDD directive, the MDR regulation has stricter and more comprehensive requirements for medical devices, and the pre-market certification review is more difficult and the certification cycle is longer, and all those changes has raised the threshold for certification.Wandong always follows high level of standard, and the full range of X-ray, CT and MRI products have been completed certification of CE MDR.Established in China, Impacting the WorldWandong Medical, as a professional manufacturer in the medical imaging industry, always adheres to technology innovation, continuously improves its quality management, and is committed to launching high-quality, high-performance, reliable products for customers all over the world.The MDR certification acts as a catalyst for Wandong to expand its coverage in the international market, accelerate the process of globalization, and contribute Chinese solutions to the health of people around the world.Beijing Wandong Medical Technology Co.,Ltd has dedicated itself to the R&D, manufacture, sales and service of medical imaging equipment for nearly 70 years.
CE认证作为产品进入欧洲市场的“签证”,是产品进入欧盟市场的强制性要求。《医疗器械(MDR)法规》(EU)2017/745于2017年5月发布,与MDD指令相比,MDR法规对医疗器械的要求更加严格和全面,上市前认证审查更加困难,认证周期更长,所有这些变化都提高了认证门槛。万东医疗始终遵循高标准,全系列X射线、CT和MRI产品已通过CE MDR认证。万东医疗成立于中国,影响世界,作为医疗影像行业的专业制造商,始终坚持技术创新,不断改进质量管理,致力于推出高质量,为世界各地的客户提供高性能、可靠的产品。MDR认证是万东扩大国际市场覆盖范围、加速全球化进程、为世界人民的健康贡献中国解决方案的催化剂。北京万东医疗科技有限公司致力于医疗影像设备的研发、制造、销售和服务已有近70年的历史。
In addition to a wide sales and service network all over China, our export destination covers more than 70 countries. With strict production and quality management, our MRI systems and major X-ray equipment are ISO/CE/FDA cleared. Over 8500 units of equipment are manufactured annually.The company philosophy, 'Precision and Vision', is our motivation to strive for advancement and innovation.SOURCE Wandong Medical.
除了遍布中国的广泛销售和服务网络外,我们的出口目的地还覆盖了70多个国家。通过严格的生产和质量管理,我们的MRI系统和主要X射线设备已通过ISO/CE/FDA认证。每年生产8500多台设备。“精准和远见”的公司理念是我们追求进步和创新的动力。来源:万东医疗。