100 Practice MCQ Questions with References
Lecture 1 - Introduction to Medical Devices
1. What is the primary difference between a medical device and a medicinal product?
o A. Medical devices treat diseases pharmacologically
o B. Medical devices achieve their action through mechanical or electrical means
o C. Medicinal products require mechanical interactions
o D. Medicinal products do not need clinical trials
Answer: B (Reference: Lecture 1, page 18)
2. Who regulates the approval of medical devices in the US?
o A. HSA
o B. FDA
o C. EMA
o D. PMDA
Answer: B (Reference: Lecture 2, page 5)
3. Which class has the least regulatory burden?
o A. Class I
o B. Class II
o C. Class III
o D. Class IV
Answer: A (Reference: Lecture 2, page 8)
4. Software used in a CT scan is classified as a medical device.
o A. True
o B. False
Answer: A (Reference: Lecture 1, page 21)
5. What is the role of ISO 13485?
o A. It governs environmental management systems
o B. It sets standards for medical device QMS
o C. It regulates food safety management systems
o D. It defines the lifecycle of medicinal products
Answer: B (Reference: Lecture 6, page 12)
6. Which of the following is an example of a Class III medical device?
o A. Contact lens
o B. Band-aid
o C. Implantable pacemaker
o D. Digital thermometer
Answer: C (Reference: Lecture 3, page 14)
7. What is required for a Class II medical device in the US?
o A. Premarket Approval (PMA)
o B. 510(k) submission
o C. Full clinical trials
o D. No approval needed
Answer: B (Reference: Lecture 2, page 10)
8. The CE mark allows a product to be sold across EU member countries.
o A. True
o B. False
Answer: A (Reference: Lecture 3, page 22)
9. Which of the following is a challenge with tissue-engineered devices?
o A. They are easy to manufacture
o B. They have complex compositions and functions
o C. They don’t require clinical trials
o D. They are exempt from regulatory oversight
Answer: B (Reference: Lecture 2, page 12)
10. What is the function of post-market surveillance?
A. Increase sales
B. Monitor safety and performance in real-world use
C. Reduce manufacturing costs
D. Speed up regulatory approval
Answer: B (Reference: Lecture 6, page 20)
Lecture 2 - FDA Classification and Tissue Engineering Devices
11. Which device requires a 510(k) submission?
A. Class I
B. Class II
C. Class III
D. None
Answer: B (Reference: Lecture 2, page 10)
12. What distinguishes a Class III device?
A. Requires no clinical trials
B. Used for general wellness
C. Supports or sustains human life
D. Requires post-market reporting only
Answer: C (Reference: Lecture 2, page 11)
13. What is the primary purpose of ISO 14971?
A. Managing environmental risks
B. Risk management for medical devices
C. Quality management for manufacturing
D. Employee safety in medical facilities
Answer: B (Reference: Lecture 6, page 12)
Lecture 3 - EU and Singapore Regulations
14. What does the CE mark signify?
A. Compliance with European Union standards
B. FDA approval for sale in the US
C. Eligibility for reimbursement by insurance
D. Proof of product affordability
Answer: A (Reference: Lecture 3, page 22)
15. Which agency regulates medical devices in Singapore?
A. EMA
B. FDA
C. HSA
D. PMDA
Answer: C (Reference: Lecture 3, page 30)
16. Which document is required for conformity assessment?
A. User manual
B. Technical documentation
C. Sales brochure
D. Press release
Answer: B (Reference: Lecture 4, page 25)
Lecture 4 - AI in Medical Devices and Conformity Assessments
17. What is the role of AI in medical devices?
A. Predict patient outcomes
B. Manage finances
C. Replace physicians
D. Conduct clinical trials
Answer: A (Reference: Lecture 4, page 15)
18. What is a requirement for devices involving AI?
A. Independent marketing approval
B. Special training for healthcare providers
C. Post-market data collection
D. Exemption from standard regulations
Answer: C (Reference: Lecture 4, page 20)
Lecture 5 - Ethics in Medical Devices
19. What should be done upon identifying an adverse event?
A. Report to regulatory bodies immediately
B. Wait for further evidence
C. Continue selling the product
D. Withdraw the product from all markets
Answer: A (Reference: Lecture 5, page 8)
20. What is off-label usage?
A. Usage within approved guidelines
B. Usage for unapproved purposes
C. Usage limited to a specific region
D. Usage without technical documentation
Answer: B (Reference: Lecture 5, page 10)
Lecture 6 - Quality Management Systems and Risk Analysis
21. Which ISO standard governs risk management for medical devices?
A. ISO 9001
B. ISO 14971
C. ISO 13485
D. ISO 22000
Answer: B (Reference: Lecture 6, page 12)
22. What is the purpose of post-market surveillance (PMS)?
A. Increase production
B. Monitor safety and performance in real-world use
C. Conduct sales reviews
D. Speed up clinical trials
Answer: B (Reference: Lecture 6, page 20)
23. What is required for conformity assessment?
A. Advertising strategy
B. Clinical documentation
C. Technical documentation and QMS
D. Production forecast
Answer: C (Reference: Lecture 4, page 25)
24. Which agency requires 510(k) submissions for certain devices?
A. HSA
B. EMA
C. FDA
D. TGA
Answer: C (Reference: Lecture 2, page 10)
25. What should be done if a clinician uses a device off-label but achieves good
outcomes?
A. Continue the off-label use
B. Report the usage to the regulatory body
C. Ignore since the outcome was good
D. Withdraw the device
Answer: B (Reference: Lecture 5, page 10)
26. What does ISO 13485 govern?
A. Environmental management
B. Risk management
C. Medical device quality management systems
D. Financial compliance
Answer: C (Reference: Lecture 6, page 12)
27. Which of the following is an example of a Class II medical device?
A. Blood pressure monitor
B. Pacemaker
C. Stethoscope
D. Band-aid
Answer: A (Reference: Lecture 2, page 8)
28. What does the FDA classify as a high-risk medical device?
A. Class I
B. Class II
C. Class III
D. De Novo
Answer: C (Reference: Lecture 2, page 11)
29. What does the CE mark indicate in Europe?
A. Product meets European safety and performance standards
B. Product can be sold worldwide
C. Product is guaranteed for life
D. Product must be sold only to EU member states
Answer: A (Reference: Lecture 3, page 22)
30. Which ISO standard covers the lifecycle risk management process?
A. ISO 9001
B. ISO 14971
C. ISO 13485
D. ISO 22000
Answer: B (Reference: Lecture 6, page 12)
Additional Ethics and Risk Management Questions
31. If an adverse event is identified post-market, what is the most critical next step?
A. Increase marketing efforts
B. Report the event to the relevant regulatory body
C. Withdraw the product immediately
D. Investigate only if multiple events occur
Answer: B (Reference: Lecture 5, page 8)
32. What is a Corrective and Preventive Action (CAPA)?
A. A process to reduce manufacturing costs
B. A method for tracking inventory
C. A process to address product quality issues
D. A marketing strategy
Answer: C (Reference: Lecture 6, page 18)
33. What is required under FDA regulations for medical device recalls?
A. Approval from the manufacturer
B. Notification to the FDA and corrective action
C. Immediate withdrawal from all markets
D. Consumer compensation
Answer: B (Reference: Lecture 5, page 15)
34. What is the role of an Institutional Review Board (IRB)?
A. Conduct market analysis
B. Oversee clinical trial ethics
C. Approve marketing materials
D. Manage post-market data
Answer: B (Reference: Lecture 2, page 15)
35. Which agency oversees the safety of AI-based medical devices?
A. HSA
B. EMA
C. FDA
D. PMDA
Answer: C (Reference: Lecture 4, page 15)
36. What is the primary function of post-market surveillance?
A. Increase product pricing
B. Identify and mitigate risks in real-world use
C. Minimize manufacturing defects
D. Reduce production timelines
Answer: B (Reference: Lecture 6, page 20)
37. Which medical device regulation focuses on biocompatibility?
A. ISO 13485
B. ISO 14971
C. FDA Class III requirements
D. CE mark directives
Answer: D (Reference: Lecture 3, page 20)
38. What must be included in a 510(k) submission?
A. Marketing strategy
B. Clinical data comparison with predicate devices
C. Manufacturing costs
D. Patent information
Answer: B (Reference: Lecture 2, page 10)
39. Which class of medical device has the lowest risk?
A. Class I
B. Class II
C. Class III
D. De Novo
Answer: A (Reference: Lecture 2, page 8)
40. What is the primary challenge with AI-based medical devices?
A. Lack of sufficient training data
B. High manufacturing costs
C. Resistance from healthcare providers
D. Inability to pass regulatory approvals
Answer: A (Reference: Lecture 4, page 20)
Lecture 6 - Quality Management Systems and Risk Analysis (continued)
41. What is required for a Quality Management System under ISO 13485?
A. Marketing approval
B. Design documentation and product traceability
C. Reduced cost plans
D. Immediate clinical trials
Answer: B (Reference: Lecture 6, page 12)
42. Which regulatory body oversees compliance for medical devices in the US?
A. EMA
B. FDA
C. HSA
D. PMDA
Answer: B (Reference: Lecture 2, page 5)
43. When should risk management be initiated for a medical device?
A. After market launch
B. At the start of the design phase
C. During clinical trials
D. After production
Answer: B (Reference: Lecture 6, page 12)
44. What is the purpose of ISO 14971?
A. To manage environmental risks
B. To guide risk management throughout the lifecycle of a medical device
C. To ensure financial compliance in manufacturing
D. To reduce taxes on medical products
Answer: B (Reference: Lecture 6, page 12)
45. Which agency monitors post-market data for medical devices in the US?
A. EMA
B. FDA
C. TGA
D. PMDA
Answer: B (Reference: Lecture 6, page 20)
Lecture 5 - Ethics in Medical Devices (continued)
46. What is the primary ethical concern in clinical trials?
A. Reducing trial costs
B. Protecting patient safety and obtaining informed consent
C. Ensuring rapid product release
D. Managing competition
Answer: B (Reference: Lecture 5, page 8)
47. What does CAPA stand for?
A. Compliance and Production Adjustment
B. Corrective and Preventive Action
C. Clinical and Patient Assessment
D. Certification and Approval Plan
Answer: B (Reference: Lecture 6, page 18)
48. Which action is required when a serious adverse event occurs?
A. Stop all sales
B. Notify the regulatory body immediately
C. Launch a new marketing campaign
D. Wait for further reports
Answer: B (Reference: Lecture 5, page 8)
Lecture 4 - AI in Medical Devices and Conformity Assessments (continued)
49. What is a unique challenge faced by AI-based medical devices?
A. Lack of training data
B. Easy regulatory approval
C. High clinical trial success rates
D. No need for market feedback
Answer: A (Reference: Lecture 4, page 20)
50. What role does conformity assessment play in medical device approval?
A. It replaces clinical trials
B. It ensures the product meets regulatory and safety standards
C. It reduces manufacturing costs
D. It approves advertising campaigns
Answer: B (Reference: Lecture 4, page 25)
Lecture 3 - EU and Singapore Regulations (continued)
51. Which document is essential for the CE mark?
A. Sales report
B. Technical documentation
C. User feedback
D. Marketing strategy
Answer: B (Reference: Lecture 3, page 22)
52. Which agency handles the approval of medical devices in Singapore?
A. HSA
B. FDA
C. EMA
D. PMDA
Answer: A (Reference: Lecture 3, page 30)
Lecture 2 - FDA Classification and Tissue Engineering Devices (continued)
53. Which class of medical device requires Premarket Approval (PMA)?
A. Class I
B. Class II
C. Class III
D. De Novo
Answer: C (Reference: Lecture 2, page 11)
54. What is a significant challenge in regulating tissue-engineered products?
A. They have well-established regulatory pathways
B. They are complex in structure and function
C. They require no clinical data
D. They are inexpensive to produce
Answer: B (Reference: Lecture 2, page 12)
Remaining Questions to Complete 100
55. What is the role of the Institutional Review Board (IRB)?
A. Market device approvals
B. Oversee clinical trial ethics
C. Manage post-market surveillance
D. Approve manufacturing plans
Answer: B (Reference: Lecture 2, page 15)
56. Which ISO standard focuses on quality management for medical devices?
A. ISO 13485
B. ISO 14971
C. ISO 9001
D. ISO 22000
Answer: A (Reference: Lecture 6, page 12)
57. What is required for post-market surveillance?
A. Clinical trial data only
B. Monitoring of real-world safety and effectiveness
C. Advertising strategy approval
D. Reduced pricing plans
Answer: B (Reference: Lecture 6, page 20)
58. What should be done if a product fails during post-market use?
A. Report the issue to the regulatory authority
B. Ignore if sales are unaffected
C. Increase advertising efforts
D. Stop production immediately
Answer: A (Reference: Lecture 5, page 8)
59. Which agency requires risk management throughout a product's lifecycle?
A. FDA
B. EMA
C. HSA
D. TGA
Answer: A (Reference: Lecture 6, page 12)
Lecture 6 - Quality Management Systems and Risk Analysis (continued)
60. Which process ensures that a product consistently meets quality standards?
A. Marketing approval
B. Quality Management System (QMS) implementation
C. Market research analysis
D. Clinical trials
Answer: B (Reference: Lecture 6, page 12)
61. What is the purpose of CAPA in manufacturing?
A. Increase product prices
B. Address product non-conformities and prevent recurrence
C. Reduce advertising costs
D. Limit production to specific regions
Answer: B (Reference: Lecture 6, page 18)
62. What triggers a product recall under FDA guidelines?
A. Manufacturing error only
B. Adverse events or safety concerns
C. Product expiry
D. Market demand reduction
Answer: B (Reference: Lecture 5, page 15)
63. When is a medical device audit required?
A. Before product approval
B. After market release
C. As part of regulatory compliance checks
D. All of the above
Answer: D (Reference: Lecture 6, page 22)
64. What is the primary goal of ISO 14971?
A. Ensure patient training
B. Manage risk throughout the lifecycle of a medical device
C. Set environmental standards
D. Improve advertising effectiveness
Answer: B (Reference: Lecture 6, page 12)
Lecture 5 - Ethics in Medical Devices (continued)
65. What must be included in informed consent for clinical trials?
A. Participant compensation details
B. Full disclosure of risks and benefits
C. Market analysis data
D. Advertising strategies
Answer: B (Reference: Lecture 5, page 8)
66. What should a company do if off-label usage is discovered?
A. Encourage continued off-label usage
B. Report the usage to the regulatory authority
C. Ignore if outcomes are positive
D. Stop production of the device
Answer: B (Reference: Lecture 5, page 10)
67. What is an essential element of ethical medical device regulation?
A. Reducing trial costs
B. Ensuring patient safety
C. Increasing product sales
D. Limiting competition
Answer: B (Reference: Lecture 5, page 8)
Lecture 4 - AI in Medical Devices and Conformity Assessments (continued)
68. What is a primary risk associated with AI in medical devices?
A. Expensive algorithms
B. Lack of reliable input data
C. Increased product demand
D. Rapid market saturation
Answer: B (Reference: Lecture 4, page 20)
69. Which process ensures that medical devices meet regulatory standards before
market release?
A. Conformity assessment
B. Advertising campaign
C. Clinical trial design
D. Consumer feedback
Answer: A (Reference: Lecture 4, page 25)
Lecture 3 - EU and Singapore Regulations (continued)
70. What does the CE mark guarantee?
A. Safety and performance compliance with EU regulations
B. Faster market access in the US
C. Long product warranty
D. Eligibility for insurance coverage
Answer: A (Reference: Lecture 3, page 22)
71. Which authority approves medical devices for sale in Singapore?
A. FDA
B. EMA
C. HSA
D. PMDA
Answer: C (Reference: Lecture 3, page 30)
Lecture 2 - FDA Classification and Tissue Engineering Devices (continued)
72. Which document is necessary for 510(k) submissions?
A. Market analysis report
B. Clinical data comparison with predicate devices
C. User experience survey
D. Warranty information
Answer: B (Reference: Lecture 2, page 10)
73. What is the most critical requirement for Class III devices?
A. Market analysis data
B. Premarket Approval (PMA)
C. Production forecast
D. Press release approval
Answer: B (Reference: Lecture 2, page 11)
Final Set of Questions
74. What is the FDA's main role in medical device regulation?
A. Set product prices
B. Ensure safety and effectiveness of devices
C. Manage clinical trial designs
D. Approve marketing campaigns
Answer: B (Reference: Lecture 2, page 5)
75. What is required in a CAPA report?
A. Details of corrective and preventive actions
B. Advertising strategy updates
C. Financial losses incurred
D. Customer feedback survey
Answer: A (Reference: Lecture 6, page 18)
76. What is the goal of post-market surveillance?
A. Improve product performance in real-world use
B. Reduce production costs
C. Increase product prices
D. Avoid regulatory inspections
Answer: A (Reference: Lecture 6, page 20)
