Medical Device Clinical Research in Turkey
Medical Device Clinical Research in Turkey
Medex, your CRO partner for conducting clinical studies in Turkey, presents a comprehensive overview of medical device clinical research.
Clinical Research: What and Why?
- Definition: A systematic investigation involving human subjects to assess the safety and/or performance of a medical device.
- Purpose: To verify or refute manufacturer claims regarding safety, performance, and benefit-risk profile.
Regulatory Framework
- Key Regulations:
- Turkish Constitution
- International Conventions (e.g., Oviedo Convention)
- Turkish Health Services Fundamental Law
- Turkish Penal Code
- Medical Device Regulation (MDR)
- Medical Device Clinical Investigation Regulation
- ISO 14155: Clinical investigation of medical devices for human subjects — Good clinical practice
- Good Clinical Practice Guideline (2015)