關于宗信
關于宗信
關于我們
北京宗信偉業科技有限公司是一家專業從事醫療器械及體外診斷試劑產業鏈相關的咨詢服務公司，為醫療器械企業提供全方位、一站式的整體策劃和解決方案等系列服務。服務內容覆蓋研發、生產、檢驗、臨床、注冊領域。
公司總部設立于北京，成立至今已在德國、日本、廣州、天津建立了多個服務網點，向世界各國的醫療器械企業提供全球法規策略、上市準入、法規符合性及各類質量管理等咨詢、培訓及輔導，并提供檢測和代理人等配套服務。
我們的目標是致力于成為企業成長道路上一 級堅實的臺階，與您共同開拓、把握機遇，夯實 發展。
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.
— 服務優勢 —
全方位解決方案
為醫療器械企業提供全方位、一站式的整體策劃和解決方案等系列服務
多地協同辦公
在德國、日本、廣州、天津建立了多個服務網點，向世界各國的醫療器械企業提供全球法規策略
縮短產品上市周期
高品質、高效率的專業化服務，縮短產品上市周期，推進產品市場化進程。
專注可靠
致力于成為企業成長道路上一級堅實的臺階，與您共同開拓、把握機遇，夯實發展。
主要業務
Main Business
?醫療器械及體外診斷試劑CFDA注冊
Medical device & In-vitro Diagnostics (IVD) CFDA Registration and Product Testing service
?注冊檢驗及動物實驗服務
Product Testing and Animal experiment
?醫療器械生產與經營許可咨詢服務
Advisory services on the permit of manufacturing and trading for medical devices
?醫療器械臨床試驗以及臨床評價服務
Medical device & In-vitro Diagnostics (IVD) Clinical Trial and Clinical Evaluation consulting and service
?歐盟CE、美國FDA準入咨詢服務
Consultation with EU CE and US FDA
.醫療器械質量體系認證咨詢服務
Medical device QMS consulting and service
?藥品包裝材料質量體系咨詢服務
Packaging material for pharmaceutical products QMS consulting and service
.滅菌服務質量體系認證
Sterilization service QMS consulting and service
.醫療器械資料翻譯服務
Translation to data and material on medical device
?醫療器械產品招商
Investment invitation for medical device products
?注冊代理人服務
Registration Attorneyship service
我們的客戶
Customers
