Download GTU BE/B.Tech 2019 Summer 8th Sem New 2180307 Regulatory Standards For Medical Devices Question Paper

Download GTU (Gujarat Technological University) BE/BTech (Bachelor of Engineering / Bachelor of Technology) 2019 Summer 8th Sem New 2180307 Regulatory Standards For Medical Devices Previous Question Paper

1
Seat No.: ________ Enrolment No.___________

GUJARAT TECHNOLOGICAL UNIVERSITY

BE - SEMESTER ?VIII(NEW) EXAMINATION ? SUMMER 2019
Subject Code:2180307 Date:15/05/2019

Subject Name:Regulatory Standards for Medical Devices

Time:10:30 AM TO 01:00 PM Total Marks: 70

Instructions:

1. Attempt all questions.

2. Make suitable assumptions wherever necessary.

3. Figures to the right indicate full marks.



MARKS

Q.1 (a) What are examples of medical devices? 03
(b) Explain the Safety testing of Medical Devices. 04
(c) What are some of the devices that are provided in combination
with drugs?
07

Q.2 (a) Draw the Organization Chart of CDSCO. 03
(b) Explain the role of below given members in EU. 1) Competent
Authority 2) Notified Body.
04
(c) Explain the main eight principles of Quality Management
Systems for Medical Devices (ISO 13485:2003) with the help of
diagram.
07
OR
(c) Is there a single entity that controls all the different regulatory
authorities in the different countries? Justify the answer.
07
Q.3 (a) Explain the categorization of medical device based on ISO 10993. 03
(b) What are the functions undertaken by DCGI and Central
Government for medical Device regulation?
04
(c) Define CE Marking? Outline the steps to achieve the CE marking
for medical device in EU.
07
OR
Q.3 (a) Explain the safety aspect for cyber-security. 03
(b) Enlist the functions undertaken by the FDA and state government
for Medical Device regulation in India
04
(c) Explain Life cycle of medical devices from research and
development until regulatory approval.
07
Q.4 (a) Give Classification of IVD Devices. 03
(b) Indicate the ISO Standards for below define task.
1) Quality management
2) Risk Management
3) Biological Evaluation
4) Clinical Trials
04
(c) Discuss the technical material and labeling requirement of medical
devices in India.
07
OR
Q.4 (a) What is the Role of CDRH department in Medical Device
Regulation?
03
(b) Define the following terms with examples. 1) Surface Contacting
Devices 2) External Communicating Devices.
04
(c) Whether Registration and import license is required for import of
nonnotified medical device in India? Justify the answer.
07
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1
Seat No.: ________ Enrolment No.___________

GUJARAT TECHNOLOGICAL UNIVERSITY

BE - SEMESTER ?VIII(NEW) EXAMINATION ? SUMMER 2019
Subject Code:2180307 Date:15/05/2019

Subject Name:Regulatory Standards for Medical Devices

Time:10:30 AM TO 01:00 PM Total Marks: 70

Instructions:

1. Attempt all questions.

2. Make suitable assumptions wherever necessary.

3. Figures to the right indicate full marks.



MARKS

Q.1 (a) What are examples of medical devices? 03
(b) Explain the Safety testing of Medical Devices. 04
(c) What are some of the devices that are provided in combination
with drugs?
07

Q.2 (a) Draw the Organization Chart of CDSCO. 03
(b) Explain the role of below given members in EU. 1) Competent
Authority 2) Notified Body.
04
(c) Explain the main eight principles of Quality Management
Systems for Medical Devices (ISO 13485:2003) with the help of
diagram.
07
OR
(c) Is there a single entity that controls all the different regulatory
authorities in the different countries? Justify the answer.
07
Q.3 (a) Explain the categorization of medical device based on ISO 10993. 03
(b) What are the functions undertaken by DCGI and Central
Government for medical Device regulation?
04
(c) Define CE Marking? Outline the steps to achieve the CE marking
for medical device in EU.
07
OR
Q.3 (a) Explain the safety aspect for cyber-security. 03
(b) Enlist the functions undertaken by the FDA and state government
for Medical Device regulation in India
04
(c) Explain Life cycle of medical devices from research and
development until regulatory approval.
07
Q.4 (a) Give Classification of IVD Devices. 03
(b) Indicate the ISO Standards for below define task.
1) Quality management
2) Risk Management
3) Biological Evaluation
4) Clinical Trials
04
(c) Discuss the technical material and labeling requirement of medical
devices in India.
07
OR
Q.4 (a) What is the Role of CDRH department in Medical Device
Regulation?
03
(b) Define the following terms with examples. 1) Surface Contacting
Devices 2) External Communicating Devices.
04
(c) Whether Registration and import license is required for import of
nonnotified medical device in India? Justify the answer.
07
2
Q.5 (a) Give Definition of Medical Device as per China. 03
(b) What are the necessary requirements for Premarket Notification
510K Submission for Medical Device?
04
(c) Describe the regulatory process of Class II & Class III US-FDA
Medical devices with the help of flowchart.
07
OR

Q.5 (a) Write a note on classification of medical devices in EU. 03
(b) Write a Short note on : CCC Mark ( China Compulsory
Certification Mark)
04
(c) Illustrate the difference between Manufacturing-Related
Regulation and Clinical Trial-Related Regulation.
07

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