| 1 x | EU-MDR 2017/745 Review for Clinical Professionals | € 234.00 |
| 1 x | GCP for Investigators: How to Qualify for Medical Device Clinical Investigations | € 95.00 |
| 1 x | ISO 14155:2020 - GCP Certificate | € 528.00 |
| 1 x | Clinical Evaluation for Market Approval | € 616.00 |
| 1 x | Ethics Committee(EC) / Institutional Review Board Requirements | € 143.00 |
| 1 x | Duplicate of wmdos-34 | € 20.00 |
| 1 x | GCP for Investigators: Clinical Investigation Close out or Termination | € 66.00 |
| 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
Add to Cart