18BM643: Medical Device Regulations and Safety BME Syllabus for BE 6th Sem 2018 Scheme VTU (Professional Elective-1)

Medical Device Regulations and Safety detailed Syllabus for Biomedical Engineering (BME), 2018 scheme has been taken from the VTUs official website and presented for the VTU students. For Course Code, Subject Names, Teaching Department, Paper Setting Board, Theory Lectures, Tutorial, Practical/Drawing, Duration in Hours, CIE Marks, Total Marks, Credits and other information, visit full semester subjects post given below. The Syllabus PDF files can also be downloaded from the official website of the university.

For all the other VTU BME 6th Sem Syllabus for BE 2018 Scheme, visit Biomedical Engineering 6th Sem 2018 Scheme.

For all the (Professional Elective-1) subjects refer to Professional Elective-1 Scheme. The detail syllabus for medical device regulations and safety is as follows.

Module 1

For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
.

Module 2

Global Harmonization Task Force (GHTF): Objectives, Scope of the four GHTF study groups, Benefits of the GHTF, Final documents from the GHTF, Global Medical Device Nomenclature (GMDN) The Food and Drug Administration: History of device regulation, Device classification, Registration and listing, The 510 (k) Process, Declaration of conformance to a recognized standard, The PMA application, Investigational Device Exemptions (IDEs), Good Laboratory Practices (GLPs), Good Manufacturing Practices(GMPs), Human Factors, Design Control, The FDA and Software, Software classification, The FDA Inspection.

Module 3

The European Union: European Directives, European Standardization Bodies, European Standards Development Process, Other European Standards Considerations, Conformity Assessment and Testing, European Organization for Testing and Certification, the NVCASE Program The Medical Devices Directives: Definition of a medical device, The Medical Devices Directives process, Choosing the appropriate directive, Identifying the applicable essential requirements, Identification of corresponding harmonized standards, Essential requirements, Classification of the medical devices, identification and choice of a notified body.

Module 4

Module 5

Software and Quality system regulation: Software as a Technology, Domestic Software Regulations, Domestic Software Standards, International Software Regulations, International Software Standards, The Move Toward One Software Standard History of the quality system regulations, Scope, General provisions, Quality system, Design controls, Document controls, Purchasing controls, Identification and traceability, Production and process controls, Acceptance activities, Non-conforming product, Corrective and preventive action

Note:

Assignments may be given on the Indian medical device regulations and medical instrument certification

Course Outcomes:

After studying this course, students will be able to:

Define and explain the basic concepts of medical device regulations
Discuss the global policies on medical device regulations
Analyze implications of the regulations
Analyze the way design concepts are imbibed in practical scenarios.

Question paper pattern:

Text Books:

Reliable Design of Medical Devices, Second Edition by Richard Fries, CRC Press, 2006
Medical Device Quality Assurance and Regulatory Compliance by Richard C Fries, CRC Press, 1998.

Reference Books:

Medical device regulations: global overview and guiding principles By Michael Cheng, World Health Organization
Product Safety in the European Union by GaborCzitan, Attila Gutassy, Ralf Wilde, TUVRheinlandAkademia, 2008.

For the detail Syllabus of all other subjects of BE (BME) 6th Sem, visit Biomedical Engineering 6th Sem Subjects.

For all (CBSE & Non-CBSC) BE/B.Tech results, visit VTU BE/B.Tech all semester results.

InI KA