| 1 x | Medical Device GCP – Investigator Certificate | € 279.00 |
| 1 x | EU-MDR 2017/745 Review for Clinical Professionals | € 234.00 |
| 1 x | The Clinical Investigation Plan | € 161.00 |
| 1 x | Effective Monitoring of Medical Device Clinical Investigations | € 1’517.00 |
| 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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