Medical Device Studies: Regulatory Requirements and Adverse Event Reporting is a course that covers topics such as:
- The requirements for vigilance reporting
- When a clinical investigation is need
- The role of The Competent Authority and how to, when to, and what to communicate with the authority
- The main changes involved with the new Medical Device Regulations
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting brings together:
- Quality assurance specialists
- Regulatory affairs specialists
- Junior clinical research associates
- Clinical research associates
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting will be held on 21-22 May 2024.