This download link is referred from the post: RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Second Semester Examination
[Time: 3 Hours] [Max. Marks: 75]
Medical Device Regulations
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Q.P. CODE: 5148
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Define and classify Medical Devices with examples. Describe the Medical Devices product life cycle management. (7+3)
- Explain the Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011)
- Classify Medical devices as per US-FDA. Discuss about Unique Device Identification of medical devices. Add a note on its implementation. (2+5+3)
- Describe in detail the process of CE certification in EU with timelines. (7+3)
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Discuss the organizational structure, purpose and working of IMDRF. (1+2+2)
- What is STED format? Write about the salient features of STED format. (2+3)
- Describe the adverse event reporting of medical devices. Add a note on its importance. (4+1)
- Discuss the process and importance of clinical investigation of Medical devices. (3+2)
- What is premarket notification (510k)? Write the regulatory approval process of premarket notification. (1+4)
- What are In vitro diagnostics directives? Write in brief about the approval process of in vitro diagnostics directives in EU. (1+4)
- Classify medical devices as per European Union directive. Discuss the important regulations of Active implantable medical device directive. (2+3)
- Describe the regulatory approval process of Medical devices in European Union.
- Discuss the clinical Trial Regulations specific for Medical Devices in Asia.
- Describe the Quality System requirements for medical devices in Japan.
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This download link is referred from the post: RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
--- Content provided by FirstRanker.com ---