Igenesis(Shanghai)Co.,Ltd.

1. Drafting the EU DoC and taking charge of technical documentation 2. Ensure medical devices comply with GSPR. 3.Communication with national CA, relevant EU Member State authorities, and EU AR regarding adverse events of placed devices. 4. Fulfill overseas medical device reporting obligations 5. Issue the statement specified in Section 4.1 of Annex XIV to IVDR 6. Upload and maintain up-to-date data in the EUDAMED. 7. Submit product registration dossiers, coordinate.

1. Verify device conformity under the manufacturer’s QMS before market placement to ensure full regulatory compliance in device design and production. 2. Establish, document, implement, maintain, update and continuously improve the quality management system for all devices 3. Participate in the compliance review of the company’s quality system documents.4. Fulfill PMS obligations and maintain system updates; manage adverse events compliance.