醫療器械的 MDR 流程
MDR 是對《醫療器械法規》的統稱。該規范于 2017 年 5 月 25 日生效，是在醫療器械合規性重新評估范圍內引入的一項安排，盡管其合規性之前已獲得認證。該規范旨在確定醫療器械是否符合新系統。?
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UDEM Certificate
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