GTU BE/B.Tech 2018 Winter Question Papers || Gujarat Technological University
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BE - SEMESTER-VIII (NEW) EXAMINATION — WINTER 2018
Subject Code: 2180307 Date: 26/11/2018
Subject Name: Regulatory Standards for Medical Devices
Time: 02:30 PM TO 05:00 PM Total Marks: 70
Instructions:
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- Attempt all questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
| Q. | Question | MARKS |
|---|---|---|
| Q.1 | (a) How are devices determined to belong to the higher risk group? | 03 |
| (b) Give definition of medical device according to US FDA and ISO 13485. | 04 | |
| (c) Give the categorization of medical devices according to ISO 10993. | 07 | |
| Q.2 | (a) What are some of the devices that are provided in combination with drugs? | 03 |
| (b) What are the driving forces behind the development of the medical device? | 04 | |
| (c) Explain Life cycle of medical devices from research and development until regulatory approval. | 07 | |
| OR | ||
| (c) Give the classification based on Singapore medical device norms. | 07 | |
| Q.3 | (a) How can a medical device improve the quality of life? | 03 |
| (b) Explain functions of DGCI and central government for medical device regulation. | 04 | |
| (c) Explain organization of CDSCO. | 07 | |
| OR | ||
| Q.4 | (a) Which Indian organization recently prices of coronary stents? Why? | 03 |
| (b) Whether Registration and import license is required for import of non-notified medical device in India? Justify the answer. | 04 | |
| (c) Write a short note on medical device regulatory in India. | 07 | |
| Q.5 | (a) Explain the safety aspect of cyber-security during the designing of Medical Devices. | 03 |
| (b) Draw regulatory process chart for Class I EU medical devices. | 04 | |
| (c) Explain the main eight principles of Quality Management Systems for Medical Devices (ISO 13485:2003) with the help of diagram. | 07 | |
| OR | ||
| (a) Explain the role of Competent Authority members in EU. | 03 | |
| (b) Define the following terms 1. Labeling 2. Post-Marketing | 04 | |
| (c) Explain the process of China Compulsory Certification Mark in detail. | 07 | |
| Q.5 | (a) Define the following terms with examples. 1) Surface Contacting Devices 2) External Communicating Devices | 03 |
| (b) Enlist the functions undertaken by the FDA and state government for Medical Device regulation in India. | 04 | |
| (c) Define CE Marking? Outline the steps to achieve the CE marking for medical device in EU. | 07 | |
| OR | ||
| (a) Is there a single entity that controls all the different regulatory authorities in the different countries? Justify the answer. | 03 | |
| (b) Ilustrate the difference between Manufacturing-Related Regulation and Clinical Trial-Related Regulation | 04 | |
| (c) Describe the regulatory process of Class II & Class III US-FDA Medical devices with the help of flowchart. | 07 |
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