Massachusetts Medical Device Quality Systems
Exam question with correct answers (100%
verified answers) plus rationales Q &A
2026 INSTANT DOWNLOAD PDF
1. What is the primary purpose of a Medical Device Quality Management
System (QMS)?
A. Increase product prices
B. Ensure consistent device safety and effectiveness
C. Reduce employee training
D. Eliminate audits
Correct Answer: B
Rationale: A QMS ensures medical devices consistently meet regulatory, safety,
and performance requirements throughout their lifecycle.
2. Which international standard is most closely associated with medical device
quality systems?
A. ISO 27001
B. ISO 14001
C. ISO 13485:2016
D. ISO 31000
Correct Answer: C
Rationale: ISO 13485:2016 is the globally recognized quality management
standard specifically for medical device manufacturers.
,3. FDA's current medical device quality regulation is known as:
A. GMP-Plus
B. QMSR
C. OSHA 1910
D. HIPAA Rule
Correct Answer: B
Rationale: The FDA Quality Management System Regulation (QMSR) became
effective in February 2026 and aligns U.S. requirements with ISO 13485.
4. Which FDA regulation governs medical device quality systems?
A. 21 CFR Part 210
B. 21 CFR Part 11
C. 21 CFR Part 820
D. 21 CFR Part 312
Correct Answer: C
Rationale: Medical device quality requirements are contained in 21 CFR Part 820
under the QMSR framework.
5. Risk management should be applied during:
A. Manufacturing only
B. Design only
C. Product lifecycle only after launch
D. Entire product lifecycle
Correct Answer: D
,Rationale: Modern quality systems require risk-based thinking throughout design,
production, distribution, and post-market activities.
6. Which document provides evidence that design controls were followed?
A. Device History Record
B. Design History File
C. Complaint Log
D. Calibration Record
Correct Answer: B
Rationale: The Design History File documents design activities and demonstrates
compliance with design control requirements.
7. CAPA stands for:
A. Corrective and Preventive Action
B. Calibration and Product Analysis
C. Customer Assessment Procedure Audit
D. Compliance Action Program Approval
Correct Answer: A
Rationale: CAPA is a systematic approach used to investigate and prevent
recurrence of quality problems.
8. A nonconforming product is a product that:
A. Exceeds customer expectations
B. Meets all specifications
C. Fails to meet specified requirements
D. Has passed inspection
, Correct Answer: C
Rationale: Nonconforming products deviate from established requirements and
require evaluation and disposition.
9. Internal audits are primarily performed to:
A. Increase sales
B. Verify QMS effectiveness
C. Replace FDA inspections
D. Avoid training
Correct Answer: B
Rationale: Internal audits assess whether processes comply with procedures and
regulatory requirements.
10. Management review should evaluate:
A. Employee salaries only
B. Market competition only
C. QMS performance and effectiveness
D. Customer demographics only
Correct Answer: C
Rationale: Management reviews ensure leadership evaluates quality objectives,
audit results, CAPA status, and system performance.
11. Traceability allows manufacturers to:
A. Eliminate documentation
B. Track products and components through production
Exam question with correct answers (100%
verified answers) plus rationales Q &A
2026 INSTANT DOWNLOAD PDF
1. What is the primary purpose of a Medical Device Quality Management
System (QMS)?
A. Increase product prices
B. Ensure consistent device safety and effectiveness
C. Reduce employee training
D. Eliminate audits
Correct Answer: B
Rationale: A QMS ensures medical devices consistently meet regulatory, safety,
and performance requirements throughout their lifecycle.
2. Which international standard is most closely associated with medical device
quality systems?
A. ISO 27001
B. ISO 14001
C. ISO 13485:2016
D. ISO 31000
Correct Answer: C
Rationale: ISO 13485:2016 is the globally recognized quality management
standard specifically for medical device manufacturers.
,3. FDA's current medical device quality regulation is known as:
A. GMP-Plus
B. QMSR
C. OSHA 1910
D. HIPAA Rule
Correct Answer: B
Rationale: The FDA Quality Management System Regulation (QMSR) became
effective in February 2026 and aligns U.S. requirements with ISO 13485.
4. Which FDA regulation governs medical device quality systems?
A. 21 CFR Part 210
B. 21 CFR Part 11
C. 21 CFR Part 820
D. 21 CFR Part 312
Correct Answer: C
Rationale: Medical device quality requirements are contained in 21 CFR Part 820
under the QMSR framework.
5. Risk management should be applied during:
A. Manufacturing only
B. Design only
C. Product lifecycle only after launch
D. Entire product lifecycle
Correct Answer: D
,Rationale: Modern quality systems require risk-based thinking throughout design,
production, distribution, and post-market activities.
6. Which document provides evidence that design controls were followed?
A. Device History Record
B. Design History File
C. Complaint Log
D. Calibration Record
Correct Answer: B
Rationale: The Design History File documents design activities and demonstrates
compliance with design control requirements.
7. CAPA stands for:
A. Corrective and Preventive Action
B. Calibration and Product Analysis
C. Customer Assessment Procedure Audit
D. Compliance Action Program Approval
Correct Answer: A
Rationale: CAPA is a systematic approach used to investigate and prevent
recurrence of quality problems.
8. A nonconforming product is a product that:
A. Exceeds customer expectations
B. Meets all specifications
C. Fails to meet specified requirements
D. Has passed inspection
, Correct Answer: C
Rationale: Nonconforming products deviate from established requirements and
require evaluation and disposition.
9. Internal audits are primarily performed to:
A. Increase sales
B. Verify QMS effectiveness
C. Replace FDA inspections
D. Avoid training
Correct Answer: B
Rationale: Internal audits assess whether processes comply with procedures and
regulatory requirements.
10. Management review should evaluate:
A. Employee salaries only
B. Market competition only
C. QMS performance and effectiveness
D. Customer demographics only
Correct Answer: C
Rationale: Management reviews ensure leadership evaluates quality objectives,
audit results, CAPA status, and system performance.
11. Traceability allows manufacturers to:
A. Eliminate documentation
B. Track products and components through production
