NPTEL : NOC:Regulatory Requirements for Medical Devices including in Vitro Diagnostics in India (Version 2.0) (Multi-Disciplinary)

Co-ordinators : Prof. Malay Mitra, Prof. Aseem Sahu, Prof. Arun B.Ramteke

Lecture 1 - Courses Overview
Lecture 2 - Medical device and in vitro diagnostics: Introduction and types of devices including combination devices
Lecture 3 - Medical Device Rules, 2017: Implications on medical devices
Lecture 4 - Classification of medical devices
Lecture 5 - Labelling of medical devices and in vitro diagnostics
Lecture 6 - Standards of medical device, quality assurance and testing
Lecture 7 - Regulatory requirements of biocompatibility of medical devices and ISO 10993
Lecture 8 - Clinical investigation of medical devices, regulation of investigational medical devices
Lecture 9 - Quality assurance and quality management system
Lecture 10 - How to obtain a licence to manufacture a medical device?
Lecture 11 - ISO 14971 (Medical devices: Application of risk management to medical devices)
Lecture 12 - Inspection of medical device and IVD establishments
Lecture 13 - Import and export of medical devices and IVDs
Lecture 14 - Medical device regulation: International practices