FirstRanker Logo

FirstRanker.com - FirstRanker's Choice is a hub of Question Papers & Study Materials for B-Tech, B.E, M-Tech, MCA, M.Sc, MBBS, BDS, MBA, B.Sc, Degree, B.Sc Nursing, B-Pharmacy, D-Pharmacy, MD, Medical, Dental, Engineering students. All services of FirstRanker.com are FREE

📱

Get the MBBS Question Bank Android App

Access previous years' papers, solved question papers, notes, and more on the go!

Install From Play Store

Download RGUHS M.Pharm 2019 June 2nd Year 5148 Medical Device Regulations Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 June (Master of Pharmacy) 1st Year (First Year) 2nd Year 5148 Medical Device Regulations Previous Question Paper

This post was last modified on 11 June 2021

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

--- Content provided by FirstRanker.com ---

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

  1. Define and classify Medical Devices with examples. Describe the Medical Devices product life cycle management. (7+3)
  2. --- Content provided by FirstRanker.com ---

  3. Explain the Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011)
  4. Classify Medical devices as per US-FDA. Discuss about Unique Device Identification of medical devices. Add a note on its implementation. (2+5+3)
  5. Describe in detail the process of CE certification in EU with timelines. (7+3)

SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks

  1. Discuss the organizational structure, purpose and working of IMDRF. (1+2+2)
  2. --- Content provided by FirstRanker.com ---

  3. What is STED format? Write about the salient features of STED format. (2+3)
  4. Describe the adverse event reporting of medical devices. Add a note on its importance. (4+1)
  5. Discuss the process and importance of clinical investigation of Medical devices. (3+2)
  6. What is premarket notification (510k)? Write the regulatory approval process of premarket notification. (1+4)
  7. What are In vitro diagnostics directives? Write in brief about the approval process of in vitro diagnostics directives in EU. (1+4)
  8. --- Content provided by FirstRanker.com ---

  9. Classify medical devices as per European Union directive. Discuss the important regulations of Active implantable medical device directive. (2+3)
  10. Describe the regulatory approval process of Medical devices in European Union.
  11. Discuss the clinical Trial Regulations specific for Medical Devices in Asia.
  12. Describe the Quality System requirements for medical devices in Japan.

FirstRanker.com

--- Content provided by FirstRanker.com ---



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 ---