Dirigeants et représentants réglementaires de Hiwin Medtech (Shenzhen) Co.,Ltd.
1 contact identifié
ZHANG Tony
1) Checking device regulatory compliance appropriately prior to medical device release in accordance with the quality management system for the manufacture of medical devices;
2) development of technical documentation and EU Declaration of Conformity and keeping them up-to-date;
3) comply with the post-market regulatory obligations under Article 10 (10) of the MDR;
4) fulfill the reporting obligations under Articles 87 to 91 of the MDR.