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. |