Minnesota Medical Device Safety Certification
Exam Question and correct answers (verified
answers 100%) Q&A 2026/2027 INSTANT
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1. What is the primary goal of medical device safety management?
A. Increase device sales
B. Reduce manufacturing costs
C. Protect patients and users from device-related harm
D. Eliminate all device recalls
Correct Answer: C
Rationale: Medical device safety focuses on minimizing risks and preventing harm
to patients, healthcare workers, and users through effective risk management and
quality controls.
2. Which organization regulates medical devices in the United States?
A. OSHA
B. FDA
C. EPA
D. CDC
Correct Answer: B
Rationale: The U.S. Food and Drug Administration (FDA), specifically the Center for
Devices and Radiological Health (CDRH), regulates medical devices.
3. ISO 14971 is primarily associated with:
,A. Medical device cybersecurity
B. Medical device risk management
C. Hospital accreditation
D. Pharmaceutical manufacturing
Correct Answer: B
Rationale: ISO 14971 provides requirements for identifying hazards, evaluating
risks, controlling risks, and monitoring medical device safety throughout the
lifecycle.
4. A hazard in medical device safety is best defined as:
A. A completed product
B. A source of potential harm
C. A manufacturing employee
D. A regulatory document
Correct Answer: B
Rationale: A hazard is a potential source of injury or damage that may occur
during device use.
5. Which process identifies possible failures before a device reaches the market?
A. Advertising review
B. Risk assessment
C. Sales forecasting
D. Inventory control
Correct Answer: B
Rationale: Risk assessment identifies hazards, estimates risks, and determines
whether safety controls are needed.
,6. Failure Mode and Effects Analysis (FMEA) is used to:
A. Design marketing strategies
B. Identify possible failure risks
C. Train sales teams
D. Approve hospital budgets
Correct Answer: B
Rationale: FMEA is a proactive risk analysis tool used to identify potential failures
and their effects before they occur.
7. The purpose of a device recall is to:
A. Increase production
B. Remove unsafe devices from use
C. Reduce employee training
D. Improve advertising
Correct Answer: B
Rationale: Recalls protect patients by correcting or removing devices that may
present safety risks.
8. Which FDA classification represents the highest-risk medical devices?
A. Class I
B. Class II
C. Class III
D. Class IV
Correct Answer: C
Rationale: Class III devices usually support life, sustain life, or present significant
risks and require the strictest controls.
, 9. A device complaint should first be evaluated for:
A. Marketing opportunities
B. Potential patient safety impact
C. Employee performance
D. Product pricing
Correct Answer: B
Rationale: Complaint handling begins with determining whether the issue could
affect patient safety or regulatory compliance.
10. Which document describes identified risks and safety controls?
A. Risk management file
B. Sales report
C. Training schedule
D. Purchase order
Correct Answer: A
Rationale: The risk management file contains documentation of risk analysis,
evaluation, controls, and verification activities.
11. Design controls are required primarily to ensure:
A. Faster product advertising
B. Safe and effective device development
C. Lower employee wages
D. Increased packaging size
Correct Answer: B
Rationale: Design controls ensure devices meet user needs, intended uses, and
safety requirements.
Exam Question and correct answers (verified
answers 100%) Q&A 2026/2027 INSTANT
DOWNLOAD PDF
1. What is the primary goal of medical device safety management?
A. Increase device sales
B. Reduce manufacturing costs
C. Protect patients and users from device-related harm
D. Eliminate all device recalls
Correct Answer: C
Rationale: Medical device safety focuses on minimizing risks and preventing harm
to patients, healthcare workers, and users through effective risk management and
quality controls.
2. Which organization regulates medical devices in the United States?
A. OSHA
B. FDA
C. EPA
D. CDC
Correct Answer: B
Rationale: The U.S. Food and Drug Administration (FDA), specifically the Center for
Devices and Radiological Health (CDRH), regulates medical devices.
3. ISO 14971 is primarily associated with:
,A. Medical device cybersecurity
B. Medical device risk management
C. Hospital accreditation
D. Pharmaceutical manufacturing
Correct Answer: B
Rationale: ISO 14971 provides requirements for identifying hazards, evaluating
risks, controlling risks, and monitoring medical device safety throughout the
lifecycle.
4. A hazard in medical device safety is best defined as:
A. A completed product
B. A source of potential harm
C. A manufacturing employee
D. A regulatory document
Correct Answer: B
Rationale: A hazard is a potential source of injury or damage that may occur
during device use.
5. Which process identifies possible failures before a device reaches the market?
A. Advertising review
B. Risk assessment
C. Sales forecasting
D. Inventory control
Correct Answer: B
Rationale: Risk assessment identifies hazards, estimates risks, and determines
whether safety controls are needed.
,6. Failure Mode and Effects Analysis (FMEA) is used to:
A. Design marketing strategies
B. Identify possible failure risks
C. Train sales teams
D. Approve hospital budgets
Correct Answer: B
Rationale: FMEA is a proactive risk analysis tool used to identify potential failures
and their effects before they occur.
7. The purpose of a device recall is to:
A. Increase production
B. Remove unsafe devices from use
C. Reduce employee training
D. Improve advertising
Correct Answer: B
Rationale: Recalls protect patients by correcting or removing devices that may
present safety risks.
8. Which FDA classification represents the highest-risk medical devices?
A. Class I
B. Class II
C. Class III
D. Class IV
Correct Answer: C
Rationale: Class III devices usually support life, sustain life, or present significant
risks and require the strictest controls.
, 9. A device complaint should first be evaluated for:
A. Marketing opportunities
B. Potential patient safety impact
C. Employee performance
D. Product pricing
Correct Answer: B
Rationale: Complaint handling begins with determining whether the issue could
affect patient safety or regulatory compliance.
10. Which document describes identified risks and safety controls?
A. Risk management file
B. Sales report
C. Training schedule
D. Purchase order
Correct Answer: A
Rationale: The risk management file contains documentation of risk analysis,
evaluation, controls, and verification activities.
11. Design controls are required primarily to ensure:
A. Faster product advertising
B. Safe and effective device development
C. Lower employee wages
D. Increased packaging size
Correct Answer: B
Rationale: Design controls ensure devices meet user needs, intended uses, and
safety requirements.
