博尼爾專(zhuān)注為醫(yī)療器械企業(yè)提供如下服務(wù)，請(qǐng)將我們的服務(wù)轉(zhuǎn)發(fā)給貴司的質(zhì)量經(jīng)理或管理者代表： 1、醫(yī)療器械質(zhì)量管理體系ISO13485認(rèn)證咨詢(xún)與輔導(dǎo)； 2、MDSAP醫(yī)療器械單一審核程序認(rèn)證咨詢(xún)與輔導(dǎo)； 3、美國(guó)FDA QSR820法規(guī)體系咨詢(xún)與輔導(dǎo)、協(xié)助FDA驗(yàn)廠服務(wù)； 4、醫(yī)療器械全球注冊(cè)服務(wù)，包括美國(guó)510k注冊(cè), 歐盟CE注冊(cè), 加拿大MDL注冊(cè)及中國(guó)CFDA注冊(cè)等； 5、醫(yī)療器械上市后法規(guī)符合性服務(wù)，如醫(yī)療器械不良事管理、醫(yī)療器械上市后跟蹤服務(wù)等； 6、醫(yī)療器械法規(guī)與質(zhì)量工具的培訓(xùn)，包括MDSAP法規(guī)、CAPA系統(tǒng)、驗(yàn)證&確認(rèn)、風(fēng)險(xiǎn)管理等 7、醫(yī)療器械中國(guó)代理人(MD delegate in China)服務(wù)為海外醫(yī)療器械生產(chǎn)企業(yè)提供ⅠⅡⅢ類(lèi)醫(yī)療器械在中國(guó)的注冊(cè)及法規(guī)符合性服務(wù)。 我們的服務(wù)將協(xié)助質(zhì)量經(jīng)理或管理者代表改進(jìn)貴司的質(zhì)量&法規(guī)體系，進(jìn)而提高產(chǎn)品的市場(chǎng)竟?fàn)幜?，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(jīng)理 18816892081 博尼爾醫(yī)療器械技術(shù)服務(wù)（廣州）有限公司 地址：廣東省廣州市天河區(qū)天河北路559號(hào)太平洋保險(xiǎn)大廈2302-B32 網(wǎng)址: www.bonnier.net.cn