Module 19: Regulation of In Vitro Diagnostic Medical Devices
| Programme | 2 |
| Lecture 1: Setting the Scene, Stuart Angell | 5 |
| Lecture 2: Classification of IVD Devices, Nancy Consterdine | 18 |
| Lecture 3: Conformity Assessment, Nancy Consterdine | 28 |
| Lecture 4: Quality Management Systems, Stuart Angell | 42 |
| Lecture 5: Technical Documentation, Ben Jacoby | 49 |
| Lecture 6: Performance Data & Product Claims, Maurizio Suppo | 81 |
| Lecture 7: Post Market Surveillance, Vigilance and FSCA, Stephen Lee | 111 |
| Lecture 8: Risk Management, Stuart Angell | 131 |
| Lecture 9: Registration, Nancy Consterdine | 149 |
| Lecture 10: Other Regulated Markets, Nancy Consterdine & Maurizio Suppo | 172 |
| Lecture 11: Other Legislationy, Nancy Consterdine | 185 |
| Lecture 12: Companion Diagnostics and the IVDR, Maurizio Suppo | 198 |
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