1. Ensure the production of device comply with quality management system and carefully inspect the conformity.
2. Draw up and update technical document as well as EU declaration of conformity.
3. Follow the post-market surveillance obligation in accordance to 10(10).
Hidden
CHANG Gwen
1. Complete the reporting obligation as requested by MDR 87-91.
2. Issue statement according to Chapter II section 4.1 in Annex XV if the device is applied for clinical trial.