Han Biomedical Inc.

1 Conformity of the devices is checked, in accordance with QMS before released; 2 The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 3 The post-market surveillance obligations are complied. 4 the reporting obligations are fulfilled including reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions, analysis of vigilance data, and implementing acts.