Semester VII · PCI syllabus 2026
Medical Devices
BP708T-E4
1 credit
Elective
Coming soon
Unit 1: Unit 1
- Introduction to Medical Devices: History and Overview of Medical Device Industry and evolving market Trends 1. (India + WW)
- GOI’s initiatives and National Medical Device Policy
Unit 2: Unit 2
- Regulatory frameworks (CDSCO; State FDA; USFDA; EU-CE, etc.)
- Medical device design and development process
- Definition and Classification of Medical Devices (India; US; EU) Medical Device Design, Biomaterials and Biocompatibility:
- Medical Device Design principles and methodologies, safety analysis
- Properties and selection of materials & biomaterials for devices
Unit 3: Unit 3
- Tissue engineering and regenerative medicine
- Biocompatibility Testing and Standards (ISO 10993) Manufacturing and Quality Systems: (based on ISO 13485 Fifth Sch of IMDR 2017)
- Good Manufacturing Practices (GMP) & Infrastructure requirements
Unit 4: Unit 4
- Quality assurance and quality control in Medical Devices
- Supply chain management (warehousing distribution)
- Risk Management (ISO 14971) Regulatory Affairs, Regulatory strategies for global market access
- Medical device regulations and standards (IMDR 2017)
- Understanding Regional Differences in Regulatory Pathways
- Regulatory submissions and approvals (India)
Unit 5: Unit 5
- Post-market surveillance and vigilance (India)
- Global Regulatory Requirements (USFDA, CE Mark, etc.)
- Case Studies of Global Regulatory Challenges Biomedical Engineering; Instrumentation: Emerging Technologies
- Principles of biomedical sensors and transducers
- Medical imaging techniques (X-ray, CT, MRI, ultrasound)
- Telemedicine and remote monitoring
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