博尼尔专注为医疗器械企业提供如下服务，请将我们的服务转发给贵司的质量经理或管理者代表： 1、医疗器械质量管理体系ISO13485认证咨询与辅导； 2、MDSAP医疗器械单一审核程序认证咨询与辅导； 3、美国FDA QSR820法规体系咨询与辅导、协助FDA验厂服务； 4、医疗器械全球注册服务，包括美国510k注册, 欧盟CE注册, 加拿大MDL注册及中国CFDA注册等； 5、医疗器械上市后法规符合性服务，如医疗器械不良事管理、医疗器械上市后跟踪服务等； 6、医疗器械法规与质量工具的培训，包括MDSAP法规、CAPA系统、验证&确认、风险管理等 7、医疗器械中国代理人(MD delegate in China)服务为海外医疗器械生产企业提供ⅠⅡⅢ类医疗器械在中国的注册及法规符合性服务。 我们的服务将协助质量经理或管理者代表改进贵司的质量&法规体系，进而提高产品的市场竟争力，谢谢您的举手之劳！ 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. 谢谢！ 王经理 18816892081 博尼尔医疗器械技术服务（广州）有限公司 地址：广东省广州市天河区天河北路559号太平洋保险大厦2302-B32 网址: www.bonnier.net.cn