| 1 x | Device Accountability | € 72.00 |
| 1 x | ISO 14155 – Clinical Investigation Close Out | € 104.00 |
| 1 x | The Case Report Form Process | € 161.00 |
| 1 x | US Safety Reporting Requirements during Pre-Market Clinical Trials v3 | € 80.00 |
| 1 x | Medical Device GCP – Investigator Certificate (v3) | € 249.00 |
| 1 x | Clinical Evaluation Report: Review for Regulatory Professionals | € 308.00 |
Clinical Evaluation Report: Review for Regulatory Professionals
Clinical Evaluation Report: Review for Regulatory Professionals
The course provides detailed insight into clinical evaluation report reviews by Notified Body and Regulatory reviewers. It particularly focuses on the aspects of clinical evaluation reports that notified bodies and regulatory authority reviewers pay attention to during the reviewing process.
The course complies with the requirements of the Medical Device Regulations, MEDDEV 2.7.1 rev 4 and the NBOG checklist for auditing clinical investigations.
2 modules
€ 308.00
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