北京宗信伟业科技有限公司

关于我们

       北京宗信伟业科技有限公司是一家专业从事医疗器械及体外诊断试剂产业链相关的咨询服务公司，为医疗器械企业提供全方位、一站式的整体策划和解决方案等系列服务。服务内容覆盖研发、生产、检验、临床、注册领域。

       公司总部设立于北京，成立至今已在德国、日本、广州、天津建立了多个服务网点，向世界各国的医疗器械企业提供全球法规策略、上市准入、法规符合性及各类质量管理等咨询、培训及辅导，并提供检测和代理人等配套服务。

        我们的目标是致力于成为企业成长道路上一 级坚实的台阶，与您共同开拓、把握机遇，夯实 发展。

About us

   Beijing ZONGXINWEIYE Technology Co., Ltd. is a company specializing in medical devices and in vitro diagnostic reagent Industrial chain related consulting services company, and offers one-stop planning and solving solution programs service.

    The company headquartered is located in Beijing, since the establishment, many service outlets have been set up in Germany, Japan, Guangzhou, Tianjin. We provide our services to medical device companies around worldwide, which include consulting and training, pre-market application, regulatory compliance, quality system management, as well as assorted services of testing and Legal Agent.

       Our goal is to become a solid step on the road to development of our customers, and help you seize the opportunities of development.

—  服务优势  —

  • 全方位解决方案

    为医疗器械企业提供全方位、一站式的整体策划和解决方案等系列服务

  • 多地协同办公

    在德国、日本、广州、天津建立了多个服务网点，向世界各国的医疗器械企业提供全球法规策略

  • 缩短产品上市周期

    高品质、高效率的专业化服务，缩短产品上市周期，推进产品市场化进程。

  • 专注可靠

    致力于成为企业成长道路上一级坚实的台阶，与您共同开拓、把握机遇，夯实发展。

主要业务

Main Business

♦医疗器械及体外诊断试剂CFDA注册

Medical device & In-vitro Diagnostics (IVD) CFDA Registration and Product Testing service

♦注册检验及动物实验服务

Product Testing and Animal experiment

♦医疗器械生产与经营许可咨询服务

Advisory services on the permit of manufacturing and trading for medical devices

♦医疗器械临床试验以及临床评价服务

Medical device & In-vitro Diagnostics (IVD) Clinical Trial and Clinical Evaluation consulting and service

♦欧盟CE、美国FDA准入咨询服务

Consultation with EU CE and US FDA

.医疗器械质量体系认证咨询服务

Medical device QMS consulting and service

♦药品包装材料质量体系咨询服务

Packaging material for pharmaceutical products QMS consulting and service

.灭菌服务质量体系认证

Sterilization service QMS consulting and service

.医疗器械资料翻译服务

Translation to data and material on medical device

♦医疗器械产品招商

Investment invitation for medical device products

♦注册代理人服务

Registration Attorneyship service

我们的客户

Customers