西门子(深圳)磁共振有限公司

西门子(深圳)磁共振有限公司
 
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全球统一的质量标准

SSMR 以客户需求为中心,全面贯彻西门子MR 全球统一标准的质量管理流程,已获得ISO9001、ISO13485 等国际质量体系证书。同时公司按照中国医疗器械监督管理条例、欧盟医疗器械指令(MDD)、美国联邦法规21CFR820, 加拿大医疗器械法规、日本药事法 (JPAL)等重要国际监管法规要求制定了严格的质量管理体系要求。此外,SSMR 的MRI 产品获得了FDA 认证、CE 认证、北美CSA (加拿大标准协会)安规认证以及中国CFDA注册认证并获得全球各主要国家主管当局的批准进入全球市场销售。

 

全球统一的产品开发流程

专业团队进行创新性产品预开发:由市场需求推动技术革新,用技术革新引领市场;

研发平台采用全球统一V模型,从零部件到系统均经过完整严密的设计和相应的严格验证;

设计更新及管理采用全球统一平台:SAP EDM及Charm(设计更新管理工具),所有部件设计标准统一, 所有零部件在全球生产基地间自由调配。

 

精益求精的生产工艺

基于与德国、英国全球统一的标准生产工艺,我们全面贯彻实施西门子独创的生产体系(SPS)和精益生产理念;

由西门子全球统一定制的行业顶尖生产设备,精确控制生产过程的每个环节;

生产全过程中都严格按照研发输出的检验点和接收标准进行检测,通过详细的作业指导书和完整的生产记录,严格控制生产过程,确保从部件生产到整机集成万无一失。
 

 

Global quality standard

Focusing on customers’ needs, SSMR comprehensively implements Siemens Healthineers quality management standard and has been certificated according to international standards ISO9001 and ISO13485. In addition, SSMR established a strict quality management system in accordance with global regulations including State Council No.650(China), European Medical Device Directive (MDD), Code of Federal Regulations 21CFR820 (USA), Canadian Medical Device Regulations and Japan MHLW Ministerial Ordinance No. 169 (PMD Act). Moreover, our products have obtained approvals issued by authorities in multiple countries, such as FDA (Food and Drug Administration) clearance, CE marking (Conformity with European), Canada Medical Device License and CFDA certification of China.

 


Global consolidated product development

• We have a professional team dedicated in innovative pre-development of products, to develop new technologies in line with market demands and lead the market with sophisticated technologies.

• V-model, the global unified R&D platform is applied for complete and rigorous design and strict verification from components to entire systems.

• SAP EDM (Engineering Data Management) and Charm (a change management tool) are adopted for design management and optimization. All spare parts are designed at the unified design standard and exchangeable among global MR bases.


Lean production engineering

• Based on global uniform production engineering with Siemens MR Headquarters and SMT, we adopt Siemens’ unique production system (SPS) and integrate the lean production concept throughout the entire production process.

• We deploy world-class manufacturing equipment customized for Siemens to precisely monitor each production step.

• Tests in accordance with inspection points and acceptance standards across the production process eliminate mistakes – from component manufacture through to systems integration. And standard operating procedures and complete documentation ensure strict control and monitoring of the production process and a high level of traceability.