好吊妞人成视频在线观看强行_欧美αⅤ一区二区_黄色网站久久免费看_在线视频免播放器a

醫(yī)療器械法規(guī)、注冊(cè)、臨床、體系認(rèn)證、信息系統(tǒng)一站式服務(wù)
24×7服務(wù)熱線:0571-86198618 簡體中文 ENGLISH
當(dāng)前位置:網(wǎng)站首頁>關(guān)于我們>新聞動(dòng)態(tài)
科普:工廠辦理醫(yī)療器械CE認(rèn)證步驟
發(fā)布日期:2021-12-28 14:46瀏覽次數(shù):2600次
最簡單的事項(xiàng),也是最重要的事項(xiàng),了解醫(yī)療器械CE認(rèn)證步驟和事項(xiàng),是做好CE認(rèn)證這么個(gè)中周期事項(xiàng)的前提條件。

最簡單的事項(xiàng),也是最重要的事項(xiàng),了解醫(yī)療器械CE認(rèn)證步驟和事項(xiàng),是做好CE認(rèn)證這么個(gè)中周期事項(xiàng)的前提條件。

醫(yī)療器械CE認(rèn)證.jpg

Step by step guide to compliance for manufacturers

The manufacturer has the main role in complying with the EU MDR. Considering that both the device and the manufacturer must comply with the EU MDR, the manufacturer has by far the largest number of obligations to fulfil.

The linked pages describe a step by step approach to compliance which should be applicable to the majority of manufacturers and devices. There is no single formula however, and the  described approach will likely require adjusting to the specifics of the manufacturer and device concerned.

Step 1: Decide the intended use and classification

Step 2: Establish the necessary processes and resources

Step 3: Minimise the risks and fulfil the general requirements

Step 4: Complete the clinical evaluation

Step 5: Compile the technical documentation

Step 6: Make arrangements for distribution

Step 7: Register the device and the manufacturer

Step 8: Complete the conformity assessment

Step 9: Complete the final administrative procedures before launch

Step 10: Fulfil the obligations of the post market phase

Any question of 醫(yī)療器械CE認(rèn)證,Please contact me freely!Mr Ye 18058734169


Copyright © 2018 醫(yī)療器械注冊(cè)技術(shù)咨詢 浙ICP備18025678號(hào) 技術(shù)支持:熙和網(wǎng)絡(luò)

新聞動(dòng)態(tài)