Medical Device2 Clinical Evaluation Report (GMED Guideline) Clinical Evaluation Report GMED에서 Medical Devices Clnical Evaluation 관련해서 가이드라인이 나왔다. Summary of safety and Clinical Performance(SSCP) Regulation (EU) 2017/745 https://lne-gmed.com/guides/medical-devices-clinical-evaluation-summary-of-safety-and-clinical-performance-sscp-regulation-eu-2017-745 Medical Devices Clinical Evaluation - Summary of Safety and Clinical Performance (SSCP) - Regulation (E.. 2022. 5. 26. Clinical Evaluation Plan (MDCG 2020-6) Clinical Evaluation Plan https://ec.europa.eu/health/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en Guidance - MDCG endorsed documents and other guidance This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017… ec.europa.eu Clinical Evaluation Plan은 MDCG Gu.. 2022. 5. 26. 이전 1 다음 728x90