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Announcement of the Hon. President Award for the 'Staff Excellence' and Hon. Director General Award for 'Student Achievements' for the academic year of 2020-2021 and 2021-22 Click here to know moreRecruitment for Homoeopathy Care & Hospital, Insti. of Homoeopathy, Nursing and Physiotherapy Click here to know morePh.D. Admission 2023 Click here  

Announcement of the Hon. President Award for the 'Staff Excellence' and Hon. Director General Award for 'Student Achievements' for the academic year of 2020-2021 and 2021-22 Click here to know moreRecruitment for Homoeopathy Care & Hospital, Insti. of Homoeopathy, Nursing and Physiotherapy Click here to know morePh.D. Admission 2023 Click here  

DIPLOMA + DEGREE BIOMEDICAL ENGINEERING

Fee and Institute

Tution Fees

₹ 43000 /- per year

Contact No.:

+91- (M) 9426381475
+91- (M) 9714161771

Email

admission.bspp2@ganpatuniversity.ac.in

Intake

40

Eligibility

Passed 10th Std./ SSC examination from a Recognized Board with minimum 35% Marks

Programme Outcome

PO -1

Graduate will demonstrate an ability to apply knowledge of mathematics, science, and Biomedical engineering to the solution of complex engineering problems.

PO -2

Graduate will demonstrate ability to Identify, formulate and solve biomedical engineering problems by integrating and applying basic principles of mathematics, life sciences, and engineering.

PO -3

Graduate will demonstrate an ability to design solutions for complex system, component, or process within a defined specification that meet specified needs with appropriate consideration for public health and safety, cultural, societal, and environmental considerations

PO -4

Graduate will demonstrate an ability to identify, formulate, investigate and synthesis of information to solve complex engineering problems.

PO -5

Graduate will demonstrate an ability to use modern science and engineering techniques, skills, and computational tools to support biomedical engineering analysis and design.

PO -6

Graduate will be able to assess societal, health, safety, legal and cultural issue

PO -7

Graduate will demonstrate an ability to create an environment to encourage and assist them self and others to become leaders in their fields.

PO -8

Graduate will demonstrate knowledge of professional and ethical responsibilities.

PO -9          

Graduate will demonstrate an ability to function effectively as an individual, and as a member or leader in diverse teams.

PO -10

Graduate will demonstrate an ability to articulate ideas, communicate effectively, in writing and verbally, on complex engineering activities with the engineering community and with society at large.

PO -11

Graduate will demonstrate knowledge and understanding of engineering and management principles to manage projects in multidisciplinary environments.

PO -12                   

Graduate will acquire and possess capacity for self education and life-long learning.

Programme Educational Objectives (PEO)

PEO - I        Graduates will be able to promote economic development through technology, entrepreneurship and innovation in the area of Biomedical Engineering and participate in lifelong learning activities.
PEO - 2Graduates will be able to exhibit effective scientific, technical, communication and resource management skills in their professional practices.
PEO - 3            Graduates will understand the human behavior, societal needs & forces and the dynamics of human efforts and their effects on human health .

Syllabus

Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
MATHEMATICS - I open 1BS121 4 Read More
Biophysics open 1BS126 4 Read More
Electronics Components & Practice open 1ES117 4 Read More
Biology open 1BS125 4 Read More
MECHANICAL WORKSHOP open 1ES115 2 Read More
Communicative English-I open 1HS121 4 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
MATHEMATICS-II open 1BS221 4 Read More
ENVIRONMENTAL STUDIES AND DISASTER MANAGEMENT open 1ES1012 2 Read More
CHEMISTRY open 1BS122 4 Read More
Anatomy & Physiology-I core 1ES212 5 Read More
BASIC ELECTRICAL & ELECTRONICS ENGINEERING open 1ES108 4 Read More
SOFTWARE TOOLS open 1ES104 1 Read More
Communicative English-II open 1HS221 1 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Analog Integrated Electronics core 1BM2301 4 Read More
Anatomy & Physiology-II core 1BM2302 5 Read More
Basics of Transducers open 1BM2303 5 Read More
Biomaterials core 1BM2304 4 Read More
Entrepreneurship Development open 1BM2305 3 Read More
Software Simulation open 1BM2306 1 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Digital Circuit Theory open 1BM2401 5 Read More
Electronic Instrumentation & Recorders open 1BM2402 4 Read More
Diagnostic Instrumentation core 1BM2403 5 Read More
Analytical Instrumentation core 1BM2404 4 Read More
Hospital Management open 1BM2405 3 Read More
Seminar open 1BM2406 1 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Microprocessor Architecture and Applications open 1BM2501 5 Read More
Biomedical Digital Signal Processing core 1BM2502 5 Read More
Instrumentation for Critical Care core 1BM2503 5 Read More
Basics of Biomechanics core 1BM2504 5 Read More
Minor Project regular 1BM2505 2 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Microcontroller Applications open 1BM2601 4 Read More
Medical Imaging & Radiology core 1BM2602 5 Read More
Therapeutic Instrumentation core 1BM2603 4 Read More
Prosthetic Devices and Implants core 1BM2604 4 Read More
Ophthalmic and Optical Instrumentation core 1BM2605 4 Read More
Laser in Medicine core 1BM2606 4 Read More
Major Project regular 1BM2607 2 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Mathematics for Biomedical Engineering open 2BS3104 4 Read More
Linear Electronics open 2BM3101 4 Read More
Biomedical Transducers & Biosensors core 2BM3102 4 Read More
Medical System Actuators core 2BM3103 4 Read More
Human Anatomy & Physiology-II core 2BM3104 5 Read More
Simulation Laboratory-I core 2BM3105 1 Read More
Audit Course audit 2AC301* 0 Attachment-1
Attachment-2
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Analog Integrated Electronics open 2BM4101 4 Read More
Control System Engineering open 2BM4102 5 Read More
Digital Logic Circuits open 2BM4103 4 Read More
Electronics Measurement and Instrumentation open 2BM4104 4 Read More
Biomaterials & Implants open 2BM4105 3 Read More
Simulation Laboratory-II open 2BM4106 1 Read More
Audit Course audit 2AC* 0 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Physiological Control Systems & Modeling open 2BM5101 4 Read More
Neural Networks and Fuzzy Logic open 2BM5102 4 Read More
Microprocessor Architecture & Interfacing open 2BM5103 4 Read More
Biological Digital Signal Processing open 2BM5104 4 Read More
Cardiovascular System and Dynamics open 2BM5105 3 Read More
Analytical Instrumentation open 2BM5106 4 Read More
APTITUDE SKILL BUILDING-I open 2HS5101 1 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Ultrasonic Imaging and Radiology open 2BM6101 4 Read More
Bio-Potential & Recorders open 2BM6102 4 Read More
Diagnostic Techniques & Instrumentation open 2BM6103 4 Read More
Microcontroller Applications open 2BM6104 4 Read More
Bioinformatics open 2BM6105 4 Read More
Hospital Management & Information System open 2BM6106 3 Read More
APTITUDE SKILL BUILDING - II open 2HS6101 1 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Advanced Medical Imaging Techniques core 2BM701 4 Read More
Biomechanics & Design Ergonomics core 2BM702 4 Read More
Therapeutic Techniques & Instrumentation open 2BM703 4 Read More
Advanced Bio-Material and Tissue Engineering core 2BM704 4 Read More
Embedded System Design open 2BM705 4 Read More
Clinical Engineering & Patient Safety core 2BM706-1 3 Read More
Medical Devices Standards & Regulations core 2BM706-2 3 <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">GANPAT UNIVERSITY </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">FACULTY OF ENGINEERING &amp; TECHNOLOGY </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Programme </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Bachelor of Technology </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Branch/Spec. </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Biomedical Engineering </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Semester </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">VII </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Version </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">2.0.0.0 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Effective from Academic Year </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">2017-18 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Effective for the batch Admitted in </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">July 2017 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Subject code </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">2BM706 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Subject Name </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Medical Devices Standards &amp; Regulations </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Teaching scheme </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Examination scheme (Marks) </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">(Per week) </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Lecture(DT) </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Practical(Lab.) </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Total </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">CE </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">SEE </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Total </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">L </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">TU </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">P </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">TW </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Credit </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">3 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">3 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Theory </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">40 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">60 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">100 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Hours </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">3 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">3 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Practical </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">- </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Pre-requisites: Basic Principle of Medical Equipment, Hospital Management, Fundamental Physics </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">Learning Outcome: </span></span></span></span><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">The educational objectives of the course are to educate students to attain the following: </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Symbol"><span style="color:#000000"> </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">To provide foundational information related to the global regulation of medical devices with emphasis placed on US, EU and </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Asia-Pacific countries. </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Symbol"><span style="color:#000000"> </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">The role of the global regulatory professional will be examined in the context of these regulatory frameworks to design </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">medical devices. </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Symbol"><span style="color:#000000"> </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Medical device regulation in the US, EU &amp; Asia- Pacific with an emphasis on the product lifecycle and an extended </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">examination of the submissions process. </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Theory syllabus </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Unit </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Content </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Hrs. </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">1 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">INTRODUCTION TO MEDICAL DEVICES AND NEED OF REGULATORY AFFAIRS </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Classification of medical devices , Steps to be considered while carrying out classification of medical devices , </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Purpose and principle for regulations, Development of regulations and safety standards for medical devices </span></span></span></div> <div><span style="font-size:11.04pt"><span style="font-family:Times New Roman"><span style="color:#000000">6 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">2 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES MANUFACTURING </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">History of ISO 13485, General requirements of ISO 13485:2012, Document required by ISO 13485:2012, Process of </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">getting ISO 13485:2012, ISO 13485 applications in EU, Canada and Japan </span></span></span></div> <div><span style="font-size:11.04pt"><span style="font-family:Times New Roman"><span style="color:#000000">5 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">3 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">THE PROCESS OF GAINING APPROVAL FOR NEW MEDICAL DEVICE </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">USA: Classification of device, Premarket submission, Documentation for necessary submission to FDA, Premarket </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">review, Final registration and listing </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">EU: Determination of device class as per Annex IX, Registration process for II(a) &amp; II(b) device, Registration process </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">for III device, Necessary documentation required for registering CE mark on medical device </span></span></span></div> <div><span style="font-size:11.04pt"><span style="font-family:Times New Roman"><span style="color:#000000">7 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">4 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">REGULATIONS AND STANDARDS IN MEDICAL DEVICES FOR USA </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">The classification of medical devices by level of risk and the regulatory controls in different countries </span></span></span></div> <div><span style="font-size:9.96pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">United States Medical Device Regulatory Framework </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Legislation and Device Laws, Total Product Life Cycle Approach, The Regulatory Environment for Bringing a </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Medical Device to Market, Regulatory Considerations to Market and Keep Devices in Distribution, Registration, </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Medical device listing, Special controls and pre-market notifications, Premarket approval, Labelling practices, Good </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">manufacturing practice &amp; Quality services, Medical device reporting, Two common pathways for pre-market </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">approval of medical devices in USA </span></span></span></div> <div><span style="font-size:11.04pt"><span style="font-family:Times New Roman"><span style="color:#000000">8 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">5 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">REGULATIONS AND STANDARDS IN MEDICAL DEVICES FOR EU EUROPEAN UNION MEDICAL </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">DEVICE REGULATORY FRAMEWORK </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">New Approach concept for European directives, Harmonized standards and various bodies in European Union, </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Overview of medical devices directives in EU, Risk based classification of medical devices as per EU standards, CE </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">mark and procedure to obtain CE mark, Essential requirements for obtaining CE mark for medical devices, Labelling </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">process, Technical documentation and Risk management system, Overview of pre-market to post-market scenario of </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">CE marked medical device </span></span></span></div> <div><span style="font-size:11.04pt"><span style="font-family:Times New Roman"><span style="color:#000000">8 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">6 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">REGULATIONS AND STANDARDS IN MEDICAL DEVICES FOR INDIA UNITED STATES MEDICAL </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">DEVICE REGULATORY FRAMEWORK </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Market overview of medical devices in India, Overview of laws governing medical devices and governing bodies, </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Classification of medical devices as per risks, Role of distributors and subsidiaries body, Product registration process </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">and Quality system regulations, Manufacturing regulations , Labelling and technical requirement, Clinical trials, </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Commercials aspects and regulations on price, Upcoming regulations on medical devices in India </span></span></span></div> <div><span style="font-size:11.04pt"><span style="font-family:Times New Roman"><span style="color:#000000">8 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Learning Assignments: </span></span></span><span style="font-size:9pt"><span style="font-family:Times New Roman,Bold"><span style="color:#000000"><span style="font-weight:bold">Assignments &amp; Case studies shall be based on the above syllabus. </span></span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Text Books: </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">1 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Handbook of Medical Device Regulatory affairs in Asia &ndash; Jack Wong, Raymond K. Y. Tong, Pan Stanford Publishing</span></span></span><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">2 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Medical Devices: Regulations, Standards and Practices &ndash; Seeram Ramakrishna, Lingling Tian, Charelene Wang, Susan Liao and </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Wee Eong Teo, Woodhead publishing house </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Reference Books </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">1 </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Medical Products and Regulatory Affairs &ndash; Pharmaceuticals, Diagnostics, Medical Device John J. Tobin and Gary Walsh, </span></span></span></div> <div><span style="font-size:9pt"><span style="font-family:Times New Roman"><span style="color:#000000">Wiley- VCH</span></span></span></div> Read More
Project-I regular 2BM707 1 Read More
Subject Name Subject Type Subject Code Subject Credit Subject Comment Attachments
Biological Digital Image Processing open 2BM8101 5 Read More
Prosthetics & Orthotics Engineering open 2BM8102 5 Read More
Transportation Phenomena in Living Systems open 2BM8103 3 Read More
Project II open 2BM8104 3 Read More
Elective II-Lasers and Optical Fibers in Medicine open 2BM81PE01 5 Read More
Biomedical Microsystems elective 2BM81PE02 5 Read More