口罩歐代MDD指令+注冊(cè)+技術(shù)文檔+符合性聲明辦理       

MDD/MDR法規(guī)），全套CE技術(shù)文件編訂， CE第四版臨床評(píng)價(jià)（MEDDEV 2.7.1 Rev 4)編寫，歐盟授權(quán)代表，歐盟自由銷售證書，ISO13485:二016，(MDSAP)審核、美國(guó)FDA注冊(cè)（含F(xiàn)DA510K申請(qǐng)），F(xiàn)DA美國(guó)代理人服務(wù)/ FDA QSR820驗(yàn)廠輔導(dǎo)及整改，F(xiàn)DA警告信應(yīng)對(duì)&RED LIST 商，歐盟授權(quán)代表，進(jìn)口商和分銷商 ?直接供給的衛(wèi)生機(jī)構(gòu)或醫(yī)療保健專業(yè)人員(Article 25). ? Store and keep the UDI for implantable devices by economic operators (Article 27.8) ? Electronic system for registration of economic operators (Article 30+Annex VI, Part A) Regulatory compliance ? It should be ensured that supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer’s organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification. ? The authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union… legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general