| 1 x | Clinical Evaluation Report: Review for Regulatory Professionals | € 308.00 |
| 1 x | GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations | € 84.00 |
| 1 x | ISO 14155_课程1_范围 | € 143.00 |
| 1 x | test training for stg env | € 12.00 |
| 1 x | second video test | € 9.00 |
| 1 x | 临床试验的启动 | € 95.00 |
| 1 x | 临床试验关闭或终止 | € 66.00 |
| 1 x | US Safety Reporting Requirements during Pre-Market Clinical Trials | € 72.00 |
| 1 x | Duplicate of wmdos-34 | € 20.00 |
| 1 x | GCP for Investigators: Clinical Investigation Close out or Termination | € 66.00 |
| 1 x | Clinical Evaluation for Market Approval | € 616.00 |
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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