| Name | Download | Download Size |
|---|---|---|
| Lecture Note | Download as zip file | 107M |
| Module Name | Download |
|---|---|
| noc20_ge14_assigment_1 | noc20_ge14_assigment_1 |
| noc20_ge14_assigment_2 | noc20_ge14_assigment_2 |
| noc20_ge14_assigment_3 | noc20_ge14_assigment_3 |
| noc20_ge14_assigment_4 | noc20_ge14_assigment_4 |
| Sl.No | Chapter Name | MP4 Download |
|---|---|---|
| 1 | Courses Overview | Download |
| 2 | Medical device and in vitro diagnostics: Introduction & types of devices including combination devices | Download |
| 3 | Medical Device Rules, 2017: Implications on medical devices | Download |
| 4 | Classification of medical devices | Download |
| 5 | Labelling of medical devices and in vitro diagnostics | Download |
| 6 | Standards of medical device, quality assurance & testing | Download |
| 7 | Regulatory requirements of biocompatibility of medical devices and ISO 10993 | Download |
| 8 | Clinical investigation of medical devices, regulation of investigational medical devices | Download |
| 9 | Quality assurance and quality management system | Download |
| 10 | How to obtain a licence to manufacture a medical device? | Download |
| 11 | ISO 14971 (Medical devices: Application of risk management to medical devices) | Download |
| 12 | Inspection of medical device and IVD establishments | Download |
| 13 | Import & export of medical devices and IVDs | Download |
| 14 | Medical device regulation: International practices | Download |
| Sl.No | Chapter Name | English |
|---|---|---|
| 1 | Courses Overview | Download Verified |
| 2 | Medical device and in vitro diagnostics: Introduction & types of devices including combination devices | Download Verified |
| 3 | Medical Device Rules, 2017: Implications on medical devices | Download Verified |
| 4 | Classification of medical devices | Download Verified |
| 5 | Labelling of medical devices and in vitro diagnostics | Download Verified |
| 6 | Standards of medical device, quality assurance & testing | Download Verified |
| 7 | Regulatory requirements of biocompatibility of medical devices and ISO 10993 | Download Verified |
| 8 | Clinical investigation of medical devices, regulation of investigational medical devices | Download Verified |
| 9 | Quality assurance and quality management system | Download Verified |
| 10 | How to obtain a licence to manufacture a medical device? | Download Verified |
| 11 | ISO 14971 (Medical devices: Application of risk management to medical devices) | Download Verified |
| 12 | Inspection of medical device and IVD establishments | Download Verified |
| 13 | Import & export of medical devices and IVDs | Download Verified |
| 14 | Medical device regulation: International practices | Download Verified |
| Sl.No | Language | Book link |
|---|---|---|
| 1 | English | Download |
| 2 | Bengali | Not Available |
| 3 | Gujarati | Not Available |
| 4 | Hindi | Not Available |
| 5 | Kannada | Not Available |
| 6 | Malayalam | Not Available |
| 7 | Marathi | Not Available |
| 8 | Tamil | Not Available |
| 9 | Telugu | Not Available |