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 PTU M-Pharma 2019 May 2nd Semester 74939 REGULATORY ASPECTS OF MEDICAL DEVICES Question Paper

Download PTU (Punjab Technical University) M-Pharma (Master of Pharmacy) 2nd Semester 74939 REGULATORY ASPECTS OF MEDICAL DEVICES Last 10 Years 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011 and 2010 Previous Question Papers.

This post was last modified on 07 December 2019

PTU M.Pharm (Master of Pharmacy) 2nd Semester Last 10 Years 2010-2020 Previous Question Papers|| Punjab Technical University


FirstRanker's choice

FirstRanker.com


Roll No. Total No. of Questions : 06
Total No. of Pages : 01

M.Pharmacy(Regulatory Affairs) (2017 Batch) (Sem.-2)

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

REGULATORY ASPECTS OF MEDICAL DEVICES

Time: 3 Hrs. Subject Code : MRA-203T
M.Code: 74939

INSTRUCTIONS TO CANDIDATES :

  1. Attempt any FIVE questions out of SIX questions.
  2. Each question carries FIFTEEN marks.

Max. Marks: 75

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

  1. a) Classify Medical Devices. (10)
    b) Discuss IVDs. (5)
  2. Explain in detail the validation and verification of Medical devices. (15)
  3. Write notes on the following :
    1. Unique device identification as per US FDA. (8)
    2. Pre-marketed approval as per US FDA. (7)
    3. --- Content provided by​ FirstRanker.com ---

  4. Discuss the major highlights for the devices and in vitro diagnostics as per European Union? (15)
  5. Discuss in detail the process for clinical investigation and evaluation of medical devices in relation to Asian Continent? (15)
  6. Write notes on the following :
    1. Summary Technical Documents. (5)
    2. Good Clinical Practice for Medical devices. (10)
    3. --- Content provided by FirstRanker.com ---

NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any page of Answer Sheet will lead to UMC against the Student.

FirstRanker.com


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


This download link is referred from the post: PTU M.Pharm (Master of Pharmacy) 2nd Semester Last 10 Years 2010-2020 Previous Question Papers|| Punjab Technical University