醫(yī)療器械的 MDR 流程
MDR 是對(duì)《醫(yī)療器械法規(guī)》的統(tǒng)稱。該規(guī)范于 2017 年 5 月 25 日生效，是在醫(yī)療器械合規(guī)性重新評(píng)估范圍內(nèi)引入的一項(xiàng)安排，盡管其合規(guī)性之前已獲得認(rèn)證。該規(guī)范旨在確定醫(yī)療器械是否符合新系統(tǒng)。?
More
機(jī)械 CE 認(rèn)證
機(jī)械 CE 認(rèn)證是在歐盟規(guī)定的條件框架內(nèi)進(jìn)行的認(rèn)證過(guò)程。該認(rèn)證旨在避免在機(jī)械的生產(chǎn)、組裝和使用過(guò)程中出現(xiàn)可能威脅人類健康和環(huán)境的負(fù)面因素。該證書證明機(jī)械設(shè)備在環(huán)境和人類健康方面符合適當(dāng)?shù)臈l件。
MoreUDEM Certificate
We crown our achievements with originality with our sector experience and expert staff, we continue to be the choice of professionals.
Without compromising our principles of impartiality, independence and confidentiality, we aim to be a leader not only in Türkiye, but also in the global market, we are expanding our international network every day.
Select the website you want to go to.
Any addresses, social media platforms, or online sources other than the specified websites do not belong to UDEM A.?. and do not reflect our organization's information. To avoid encountering false or misleading information, we recommend obtaining information only through these official websites.