博尼爾專注為醫療器械企業提供如下服務，請將我們的服務轉發給貴司的質量經理或管理者代表： 1、醫療器械質量管理體系ISO13485認證咨詢與輔導； 2、MDSAP醫療器械單一審核程序認證咨詢與輔導； 3、美國FDA QSR820法規體系咨詢與輔導、協助FDA驗廠服務； 4、醫療器械全球注冊服務，包括美國510k注冊, 歐盟CE注冊, 加拿大MDL注冊及中國CFDA注冊等； 5、醫療器械上市后法規符合性服務，如醫療器械不良事管理、醫療器械上市后跟蹤服務等； 6、醫療器械法規與質量工具的培訓，包括MDSAP法規、CAPA系統、驗證&確認、風險管理等 7、醫療器械中國代理人(MD delegate in China)服務為海外醫療器械生產企業提供ⅠⅡⅢ類醫療器械在中國的注冊及法規符合性服務。 我們的服務將協助質量經理或管理者代表改進貴司的質量&法規體系，進而提高產品的市場竟爭力，謝謝您的舉手之勞！ Main business for Bonnier： 1. Consultant Service for the Accreditation of ISO13485 Quality Management System. 2. Consultant Service for the Accreditation of Medical Device Single Audit Program. 3. Consultant Service for the Accreditation of FDA CFR820 Regulation Requirement and Accompanying Service of Factory Auditing. 4. Overworld Medical Device Registration Service, Including USA 510k, Europe CE, Canada MDL and China CFDA Registration. 5. Medical Device Post Market Service, as Medical Device Adverse Event Reporting, Post-market Follow-up Service etc. 6. Training for Medical Device Regulation and Quality Tools, as MDSAP regulation, EU MDR, CAPA System, Verification & Validation, Medical Device Risk Management etc. 7. The service of Medical Device delegate in China will assist oversee Medical Device Manufacturer on registration in China for classⅠⅡⅢ Medical Device and on regulation compliance in China. Our service will assist quality manager and quality representative to improve the performance of quality & regulatory for medical device, Pls feel free to contact with us. 謝謝！ 王經理 18816892081 博尼爾醫療器械技術服務（廣州）有限公司 地址：廣東省廣州市天河區天河北路559號太平洋保險大廈2302-B32 網址: www.bonnier.net.cn