Medical Equipment Development and Manufacturing: the CME Advantage 医疗设备开发和制造：CME 的优势
CME offers a sophisticated, one-stop solution for medical electronics, from drafting specifications through ramping up mass production. CME 为医疗电子产品提供复杂的一站式解决方案，从起草规格到提高批量生产。
Five points of excellence set us apart 五大卓越点让我们与众不同
1
A proven technological track record that builds trust 建立信任的成熟技术记录
Electronic Circuit Design / Firmware Design / PC Application Design 电子电路设计 / 固件设计 / PC 应用程序设计
2 Design and development that meet stringent standards for medical devices 2 符合严格医疗器械标准的设计和开发
3 End-to-end manufacturing, from design through delivery 3 从设计到交付的端到端制造
C Certified manufacturing and quality management (ISO 13485:2016) C 认证制造和质量管理 （ISO 13485：2016）
5 Full-service OEM medical equipment supply 5 全方位服务 OEM 医疗设备供应
Overview 概述
Company Name Chief Executive Officer Location Phone / Fax Chopital Established Licenses held 公司名称 首席执行官 位置 电话/传真 Chopital 已建立 持有许可证
Certifications held Major business areas 获得认证主要业务领域
COSMIC ME Co., Inc. COSMIC ME 公司
Mitsuo Igarashi
2-31-3 Shibashimo, Kawaguchi, Saitama 333-0848 Japan 2-31-3 Shibashimo， 河口市， 埼玉县 333-0848 日本
+81 48-268-9811/ +81 48-269-0845 10,000,000 JPY +81 48-268-9811/ +81 48-269-0845 10,000,000 日元
Medical device licenses for humans : First class medical device marketing license (No. 11B1X10022) / Medical equipment manufacturing license(Registration No. 11BS200248) / Medical equipment repair business license (No. 11BS200248 - for therapeutic devices, equipment for medical clinics, physiotherapy devices and related equipment)/Marketing license for specially-controlled medical devices (No. 812738) - Medical device licenses for animals : Second class veterinary medical device marketing license (No.186/29) / Veterinary medical equipment manufacturing license (No. 552/29) / Marketing license for veterinary-controlled medical device ISO13485:2016 人体医疗器械许可证 ： 第一类医疗器械销售许可证 （编号 11B1X10022） / 医疗器械制造许可证 （注册号 11BS200248） / 医疗器械修理经营许可证 （用于治疗器械、医疗诊所设备、理疗器械及相关设备） /特殊管理医疗器械销售许可证 （编号 812738） - 动物医疗器械许可证 ： 第二类兽用医疗器械营销许可证 （No.186/29） / 兽用医疗设备制造许可证 （No.552/29） / 兽用医疗器械销售许可证 ISO13485：2016
Design, development, manufacture and sales of medical equipment and devices; import and export of medical equipment and devices. 医疗设备和器械的设计、开发、制造和销售;医疗器械和器械的进出口。
PRODUCT GUIDE 产品指南
Production workflow from design through shipping * this example applies to medical electronics 从设计到运输的生产工作流程 * 此示例适用于医疗电子产品
From the time Cosmic ME was founded, we have worked to develop a wide variety of electronic medical equipment Our track record of technological excellence and our tradition of quality craftsmanship allow us to meet the challenges of increasing diversification and ever stricter regulation that define the era. We welcome inquiries from companies looking to leverage CME expertise, in order to move quality medical electronics off the drawing board and into production. 从 Cosmic ME 成立以来，我们一直致力于开发各种电子医疗设备。我们卓越的技术记录和优质工艺的传统使我们能够应对日益多样化和日益严格的监管挑战，这些挑战定义了这个时代。我们欢迎希望利用 CME 专业知识的公司进行咨询，以便将优质医疗电子产品从绘图板转移到生产中。
