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  • Online Training Course

    NO. Training Course Training Time
    1 IVD European Regulation Jan.
    2 Introduction on EU Representative Service Feb.
    3 Requirements for NotifiedBody CE project customers Apr.
    4 Requirements and Management of clean Plant Facilities (PART 1) May.
    5 Requirements and Management of clean Plant Facilities (PART 2) May.
    6 Requirements and key points on manufacturing quality process of medical devices May.
    7 Requirements of internal audit and management review of medical device enterprises & process of corrective and preventive measures May.
    8 ISO13485 Medical device quality management system standard overview Jun.
    9 EU Representative Service basic concept and necessary requirements for compliance Jul.
    10 Overview of international market access regulations for walking aids Jul.
    11 European Medical device product classification and registration path Aug.
    12 Understanding of testing standards for walking aids marketing in the US and EU Aug.
    13 Common risks and precautions during Representative Service for medical device products Sept.
    14 Eu IVDR technical documentation preparation and requirements Sept.
    15 Eu UDI implementation and compliance Oct.
    16 European Union medical device MDR regulation overview Oct.
    17 Understanding of free sale certificate and embassy certification Nov.
    18 American medical device regulatory training Nov.
    19 Frequently asked Questions on eu Authorized Representative services and case analysis for competent authorities Dec.
    20 Interpretation of biocompatibility of medical devices Dec.