Recuritment for Various Position Click here to know more Ph.D Admission- July 2022 Click here to know more Open House -2022 Click here to know more
DIPLOMA + DEGREE BIOMEDICAL ENGINEERING
Fee and Institute
Institute Name
Ganpat University-Institute of Technology
Tution Fees
₹ 43000 /- per year
Contact No.:
+91- (M) 9426381475
+91- (M) 9714161771
admission.bspp2@ganpatuniversity.ac.in
Intake
40
Eligibility
Passed 10th Std./ SSC examination from a Recognized Board with minimum 35% Marks
Syllabus
| Subject Name | Subject Type | Subject Code | Subject Credit | Subject Comment | Attachments |
|---|---|---|---|---|---|
| MATHEMATICS - I | open | 1BS121 | 4 |
Read More |
|
| COMMUNICATIVE ENGLISH - I | open | 1HS121 | 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 |
| Subject Name | Subject Type | Subject Code | Subject Credit | Subject Comment | Attachments |
|---|---|---|---|---|---|
| MATHEMATICS-II | open | 1BS221 | 4 |
Read More |
|
| COMMUNICATIVE ENGLISH - II | open | 1HS221 | 1 |
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 |
| 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 MC | 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 MC | 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 & 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 & 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 & 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) & 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 & 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 & 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 – 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 – 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 – 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 |