Page 98 - R2017 Final_BE Biomedical Curriculum and Syllabus - REC

Department of BME, REC

UNIT IV TESTING AND VALIDATION 9
Introduction to Biostatistics, Statistical analysis for product and design validation, Clinical trials,
Calibration, Challenges in biomedical research, Case study on launch of new biomedical device.

UNIT V BUSINESS DYNAMICS ENGINEERING SERVICES INDUSTRY 9
The Industry - Engineering Services Industry - Product development in Industry versus Academia -
The IPD Essentials - Introduction to vertical specific product development processes -
Manufacturing/Purchase and Assembly of Systems - Integration of Mechanical, Embedded and
S/W systems – Product development Trade-offs - Intellectual Property Rights and Confidentiality -
Security and configuration management.
TOTAL: 45 PERIODS
OUTCOMES:
On completion of the course students will be able to
• Propose a new biomedical product and explain the clinical need
• Solve specific problems independently with necessary regulatory and safety norms
• Device equipment for drug manufacturing and testing
• Develop documentation, test specifications and coordinate with various teams for validation
and testing
• To know the market requirement and customize the product

TEXT BOOKS:
1. Beth Ann Fiedler, Managing medical devices within a regulatory framework, Elsevier,
2017
2. Benjamin Blass, Basic Principles of Drug Discovery and Development, 1st Edition, Elsevier.
3. Ezekiel J. Emanuel, Ethical and Regulatory Aspects of Clinical Research: Readings and
Commentary, 1st Ed., The Johns Hopkins University Press; first Edition, 2003.
4. Davis, Organizational Behavior, Tata McGraw Hill, Eleventh Edition, New Delhi, 2005.
5. Ira R. Berry,The Pharmaceutical Regulatory Process (Drugs and the Pharmaceutical
Sciences), First Edition., Informa HealthCare, 2004.

BM17E24 EMBEDDED SYSTEMS AND APPLICATION DEVELOPMENT L T P C
3 0 0 3

OBJECTIVES
• Understand the fundamentals of Embedded processor Modeling , Bus Communication in
processors, Input/output interfacing
• Get introduced on processor scheduling algorithms , Basics of Real time operating system

UNIT I INTRODUCTION TO EMBEDDED SYSTEMS 8
Introduction to Embedded Systems – The build process for embedded systems- Structural units in
Embedded processor , selection of processor & memory devices- DMA – Memory management
methods- Timer and Counting devices, Watchdog Timer, Real Time Clock- Software Development
tools-IDE, assembler, compiler, linker, simulator, debugger.

UNIT II EMBEDDED NETWORKING AND INTERRUPTS SERVICE MECHANISM 10
Embedded Networking: Introduction, I/O Device Ports & Buses– Serial Bus communication
protocols-RS232 standard – RS485 –USB- CAN Bus – Inter Integrated Circuits (I2C) – interrupt
sources, Programmed-I/O busy-wait approach without interrupt service mechanism-ISR concept—

Curriculum and Syllabus | B.E Biomedical Engineering | R 2017 Page 98