Ensure device is established,implemented, and maintained that matches the risk level and category and QMS complies with the MDR ;TCF and DOC are drafted; the PMS meets the requirements of MDR Article 10; there is a corrective action system for recording and reporting adverse events and on-site safety as described in Article 87 and 88 of the MDR within the company; and when it comes to devices for clinical trials, the statement described in Section 4.1 of Chapter II of Appendix XV is issued.