Medical Devices (Theory)

• The objectives of this course are to:
• Understand the Evolution and Regulatory Landscape: Gain insights into the history, market trends, and regulatory frameworks governing medical devices in India and globally.
• Master Design and Biocompatibility Principles: Learn the principles of medical device design, selection of materials, and the importance of biocompatibility in device development.
• Implement Quality Systems in Manufacturing: Understand the application of Good Manufacturing Practices (GMP), quality assurance, and risk management in medical device production.
• Navigate Regulatory Affairs for Global Market Access: Acquire knowledge of regulatory requirements and strategies for medical device approval and post-market surveillance in various regions.
• Explore Emerging Technologies in Biomedical Engineering: Investigate the integration of electronics, sensors, and software in medical devices, and address ethical considerations in their development and use.

After completion of the course student will be able to:

1. CO1Analyze Market Trends and Regulatory Policies: Assess the evolution of the medical device industry and the impact of regulatory frameworks on market dynamics across regions.
2. CO2Design Safe, Effective, and Compliant Medical Devices: Apply design principles, emerging technologies (sensors, electronics, software), and appropriate biomaterials to develop medical devices that ensure safety, efficacy, biocompatibility, and functionality.
3. CO3Implement Quality and Risk Management Systems: Apply ISO 13485 standards, risk management processes, and ethical principles to ensure quality, safety, and responsible device development.
4. CO4Navigate Global Regulatory Pathways: Understand and apply regulatory approval processes for medical devices in India, the US, the EU, and other regions.
5. CO5Develop Post-Market Surveillance Strategies: Design and implement strategies to monitor performance, safety, and compliance of medical devices after market launch.

1. Ramakrishna, S., Mayer, J., Wintermantel, E., Leong, K. W. Biomedical Materials and Devices. Springer, Singapore.
2. Enderle, J. D., Bronzino, J. D., Blanchard, S. M. Introduction to Biomedical Engineering. Academic Press (Elsevier).
3. Bronzino, J. D., Peterson, D. R. (Eds.) The Biomedical Engineering Handbook. CRC Press, Taylor & Francis.
4. Ratner, B. D., Hoffman, A. S., Schoen, F. J., Lemons, J. E. Biomaterials Science: An Introduction to Materials in Medicine. Academic Press (Elsevier).
5. Walsh, S. T. Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Academic Press (Elsevier).
6. FDA / CDSCO. Medical Device Regulations and Regulatory Affairs. Government Publications (USFDA / Government of India).
7. Sharma, S. K. Medical Device Design and Development. McGraw-Hill Education.
8. Bhat, S., Kotian, S. Biomedical Instrumentation. PHI Learning Pvt. Ltd.
9. Webster, J. G. (Ed.) Medical Instrumentation: Application and Design. Wiley India.
10. ISO / BIS. Quality Management Systems for Medical Devices (ISO 13485 & ISO 14971). International Organization for Standardization.
11. Fitzpatrick, R., et al. Ethics and Regulation of Medical Devices. Oxford University Press.
12. Panchal, H., Patel, D. Regulatory Affairs for Medical Devices. PharmaMed Press. Course Title Course Type