GS Medical Co., Ltd.

1. Update from MDCG Guidelines,EU MDR, EN Harmonized standards, Common specification. 2. Responsibility for technical document management, DoC, CE certification, CE certificate, EU authorized representative communication. 3. GSPR monitoring of clinical assessments, risk management, and preclinical assessments. 4. Responsibility for reporting changes in technical documents, quality systems, products, etc. 5. Auditor's role in MDR CE certification.

1. Monitoring the establishment, documentation, and performance of EU MDR legislation requirements for quality systems. 2. Responsibility and authority for follow-up management and reporting by regulatory authorities after European certification of medical devices. 3. Responsibility for updating and reporting changes to quality systems, technical documents, products, etc. 4. The role of the principal and watchdog in the European Certification Conformity Assessment Review.