Module NameDownload


Sl.No Chapter Name MP4 Download
1Courses OverviewDownload
2Medical device and in vitro diagnostics: Introduction & types of devices including combination devicesDownload
3Medical Device Rules, 2017: Implications on medical devicesDownload
4Classification of medical devicesDownload
5Labelling of medical devices and in vitro diagnosticsDownload
6Standards of medical device, quality assurance & testingDownload
7Regulatory requirements of biocompatibility of medical devices and ISO 10993Download
8Clinical investigation of medical devices, regulation of investigational medical devicesDownload
9Quality assurance and quality management systemDownload
10How to obtain a licence to manufacture a medical device?Download
11ISO 14971 (Medical devices: Application of risk management to medical devices)Download
12Inspection of medical device and IVD establishmentsDownload
13Import & export of medical devices and IVDsDownload

Sl.No Chapter Name English
1Courses OverviewPDF unavailable
2Medical device and in vitro diagnostics: Introduction & types of devices including combination devicesPDF unavailable
3Medical Device Rules, 2017: Implications on medical devicesPDF unavailable
4Classification of medical devicesPDF unavailable
5Labelling of medical devices and in vitro diagnosticsPDF unavailable
6Standards of medical device, quality assurance & testingPDF unavailable
7Regulatory requirements of biocompatibility of medical devices and ISO 10993PDF unavailable
8Clinical investigation of medical devices, regulation of investigational medical devicesPDF unavailable
9Quality assurance and quality management systemPDF unavailable
10How to obtain a licence to manufacture a medical device?PDF unavailable
11ISO 14971 (Medical devices: Application of risk management to medical devices)PDF unavailable
12Inspection of medical device and IVD establishmentsPDF unavailable
13Import & export of medical devices and IVDsPDF unavailable


Sl.No Language Book link
1EnglishNot Available
2BengaliNot Available
3GujaratiNot Available
4HindiNot Available
5KannadaNot Available
6MalayalamNot Available
7MarathiNot Available
8TamilNot Available
9TeluguNot Available