1.对有关上市后监督的法规不了解。2.搜集和学习《MEDDEV 2.1

1.对有关上市后监督的法规不了解。
2.搜集和学习《MEDDEV 2.12/1 rev8》,《MEDDEV 2.12/2 rev2》.此两个法规。
3.更新风险管理报告和临床评估报告。

結果 (英文) 1:

1. the regulations do not understand about the postmarket surveillance.2. the collection and study of the MEDDEV 2.12/1 rev8, the MEDDEV 2.12/2 REV2. these two regulations.3. update the risk management and clinical assessment.

結果 (英文) 2:

1. After the relevant market surveillance regulations do not understand.
2. collect and study "MEDDEV 2.12 / 1 rev8", "MEDDEV 2.12 / 2 rev2". This two regulations.
3. Update the risk management reporting and clinical assessment.

結果 (英文) 3:

1 laws and regulations related to the supervision of the listing does not understand.2 collect and study "2.12/1 rev8 MEDDEV", "2.12/2 rev2 MEDDEV". These two laws and regulations.3 Update risk management report and clinical assessment report.