Medical Device Regulations detail syllabus for Biomedical Engineering (BME), 2017 scheme is taken from VTU official website and presented for VTU students. The course code (17BM832), and for exam duration, Teaching Hr/week, Practical Hr/week, Total Marks, internal marks, theory marks, duration and credits do visit complete sem subjects post given below.
For all other bme 8th sem syllabus for be 2017 scheme vtu you can visit BME 8th Sem syllabus for BE 2017 Scheme VTU Subjects. For all other Professional Elective-V subjects do refer to Professional Elective-V. The detail syllabus for medical device regulations is as follows.
Module 1
The medical device as an entity: What is a medical device?, Defining the device, The product definition process, Overview of quality function deployment, The QFD process, The business proposal Reliability: Definition, Quality Vs Reliability, Reliability Vs Unreliability, Types of Reliability, Optimizing reliability, Reliabilitys effects on medical devices. Concept of Failure: Causes of Failure, Practical aspects of failure, Failure rates, Hardware failure, Software Failure, Failure due to human errors, Failures from customers point of view. Safety and Risk Management: Medical device safety and risk management, Effectiveness/performance of medical devices, Phases in the life span of a medical device, The risk management processes, Tools for risk estimation, Participants in ensuring the safety of medical devices, The role of each participant/stakeholder, Shared responsibility for medical device safety and performance.
Module 2
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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
Standards and Regulations Background: Standards: What are standards? Voluntary and mandatory standards, Standards development process, Conformity assessment with standards, National and international standards systems, Identification of standards, Current trends in the use of standards in medical device regulations. The ISO 9000 Series of Standards.
Module 5
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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:
- The question paper will have TEN questions.
- Each full question carry 16 marks.
- There will be TWO full questions (with maximum of THREE sub questions) from each module.
- Each full question will have questions covering all the topics under a module.
- The students will have to answer FIVE full questions, selecting ONE full question from each module.
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 detail syllabus of all other subjects of BE Bme, 2017 regulation do visit Bme 8th Sem syllabus for 2017 Regulation.
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