Quality Control and Regulatory Aspects in Medical Devices detailed syllabus scheme for Biomedical Engineering (BM), 2018-19 onwards has been taken from the DBATU official website and presented for the Bachelor of Technology students. For Subject Code, Course Title, Lecutres, Tutorials, Practice, Credits, and other information, do visit full semester subjects post given below.
For 4th Sem Scheme of Biomedical Engineering (BM), 2018-19 Onwards, do visit BM 4th Sem Scheme, 2018-19 Onwards. For the Elective-II scheme of 4th Sem 2018-19 onwards, refer to BM 4th Sem Elective-II Scheme 2018-19 Onwards. The detail syllabus for quality control and regulatory aspects in medical devices is as follows.
Quality Control and Regulatory Aspects in Medical Devices Syllabus for Biomedical Engineering (BM) 2nd Year 4th Sem 2018-19 DBATU
Course Objectives:
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Course Outcomes:
- To understand the various quality standards and regulations used for healthcare
- To get an overview of various methodologies used for management in healthcare
Unit I
Fundamentals Of Quality Management
Definition of Quality, Dimensions of Quality, Quality Planning – Quality costs. Analysis Techniques of quality Cost – Basic concepts of Total Quality Management, Historical Review. -Principles of TQM, Leadership – Concepts, Role of Senior Management – Quality Council, Quality Statements – Strategic Planning – Deming Philosophy – Barriers to TQM Implementation
Unit II
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Unit III
Statistical Process Control
Seven Tools of Quality: I, II, and III – Concept of Six Sigma: I and II – New Seven Management tools: I and II – Statistical Fundamentals – Measures of central Tendency and Dispersion, Population and Sample – Normal Curve, Control Charts for variables and attributes, Process capability
Unit IV
Tqm Tools
Benchmarking – Reasons to Benchmark – Benchmarking Process – Quality Function Deployment (QFD) – House of Quality – QFD Process – Benefits Taguchi Quality, Loss Function – Total Productive Maintenance (TPM) – Concept, Improvement Needs – FMEA -Stages of FMEA
Unit V
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
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Reference Books:
- Rose J.E, Total Quality Management, Kogan Page Ltd., 1993.
- Cesar A. Cacere and Albert Zana, The Practise of clinical Engineering, Academic Press, Newyork, 1997.
- John Bank, “The Essence of Total Quality Management”, Prentice Hall of India, 1993.
- Webster J G, and Albert Cook M, Clinical Engineering, Principles and Practices, Prentice Hall Inc., Engle wood cliffs, New Jersey, 1979.
For detail syllabus of all subjects of Biomedical Engineering (BM) 4th Sem 2018-19 onwards, visit BM 4th Sem Subjects of 2018-19 Onwards.