Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 5: Developing Clinical Evaluations (2021)
Medical Devices
Global Harmonization Task Force (GHTF)
Clinical Evaluation
Clinical Evaluation Report (CER),
Essential Principles (EP)
Appraisal Process
Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 2: Clinical Investigation: Principles from Harmonized Documents (2021)
Medical Devices
Guidances
International Medical Device Regulators Forum (IMDRF)
Global Harmonization Task Force (GHTF)
Harmonization
Standards