Clinical Evaluation Report
GMED에서 Medical Devices Clnical Evaluation 관련해서 가이드라인이 나왔다.
Summary of safety and Clinical Performance(SSCP) Regulation (EU) 2017/745
Medical Devices Clinical Evaluation - Summary of Safety and Clinical Performance (SSCP) - Regulation (EU) 2017/745 - GMED Medica
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This guide recalls the principles of clinical evaluation and describes the different elements to be included in:
The clinical evaluation plan
The clinical evaluation report
The post-market surveillance plan including the post-market clinical follow-up (PMCF) plan
The PMCF evaluation report
해당 가이드는 임상평가계획, 임상평가보고서, PMS/PMCF계획, PMCF보고서를 포함한다.
Clinical Evaluation Report 관련해서는 p.15부터 참고하면 된다.
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