| 1 x | Introduction to Good Clinical Practice | € 109.00 |
| 1 x | Safety Reporting Requirements 2 course Suite | € 106.00 |
| 1 x | ISO 14155:2020 - Ethical Considerations | € 108.00 |
| 1 x | Clinical Evaluation for Market Approval | € 352.00 |
| 1 x | EU-MDR 2017/745 Review for Clinical Professionals | € 234.00 |
| 1 x | US Safety Reporting Requirements during Pre-Market Clinical Trials | € 72.00 |
US Safety Reporting Requirements during Pre-Market Clinical Trials
US Safety Reporting Requirements during Pre-Market Clinical Trials
This course outlines the safety reporting requirements for significant and non-significant risk device clinical investigations in the US. The content adheres to the US FDA and US Institutional Review Boards.
This course applies the requirements from CFR 812.150.
2 modules
€ 72.00
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