Validation, verification and adverse event reporting for devices MCQs With Answer

Introduction:
This quiz collection on Validation, Verification and Adverse Event Reporting for Devices is designed for M.Pharm students studying Regulatory Aspects of Medical Devices (MRA203T). It focuses on the practical and regulatory distinctions between verification and validation, process and software validation requirements, and post-market adverse event reporting obligations under major regulatory frameworks. Questions emphasize standards and guidance such as ISO 13485, ISO 14971, IEC 62304, FDA 21 CFR parts relevant to design controls and MDRs, plus databases like MAUDE and EUDAMED. Use these MCQs to reinforce decision-making skills for device quality systems, risk management, and vigilance responsibilities encountered in pharmaceutical regulatory practice.

Q1. What is the primary difference between verification and validation in medical device development?

• Verification confirms the product meets user needs and intended use; validation checks design outputs against design inputs.
• Verification ensures design outputs meet design inputs; validation confirms the device meets user needs and intended use.
• Verification is only performed after market release; validation is only done during design transfer.
• Verification is applicable to software only; validation is applicable to hardware only.

Correct Answer: Verification ensures design outputs meet design inputs; validation confirms the device meets user needs and intended use.

Q2. Which FDA regulation specifically requires design validation and verification as part of design controls?

• 21 CFR 820.75
• 21 CFR 820.30
• 21 CFR 11
• 21 CFR 803

Correct Answer: 21 CFR 820.30

Q3. Under ISO 13485, when is process validation required?

• Only for sterile manufacturing processes.
• When the process output cannot be fully verified by subsequent monitoring and measurement of the product.
• Only for software development processes.
• Process validation is optional under ISO 13485.

Correct Answer: When the process output cannot be fully verified by subsequent monitoring and measurement of the product.

Q4. Which database is curated by the FDA to collect medical device adverse event reports from manufacturers and user facilities?

• Vigilance
• EUDAMED
• MAUDE
• ISO MedWatch

Correct Answer: MAUDE

Q5. Who typically has the primary regulatory responsibility to report device-related adverse events to the competent authority?

• The end-user clinician only
• The hospital procurement department
• The device manufacturer
• The notified body

Correct Answer: The device manufacturer

Q6. Which international standard specifically addresses the life-cycle processes for medical device software?

• ISO 10993
• IEC 62304
• ISO 13485
• IEC 60601

Correct Answer: IEC 62304

Q7. According to regulatory guidance, process validation is most critical when:

• The product can be fully inspected and tested at the end of production.
• The manufacturing process is manual and low risk.
• The process produces outputs that cannot be fully verified by final testing.
• The device is a simple non-sterile accessory.

Correct Answer: The process produces outputs that cannot be fully verified by final testing.

Q8. Under FDA recall classifications for medical devices, which class indicates a reasonable probability of serious adverse health consequences or death?

• Class III
• Class II
• Class I
• Class IV

Correct Answer: Class I

Q9. Which activity is typically part of design validation rather than design verification?

• Bench testing to prove electrical output meets a specification.
• Clinical evaluation to confirm the device meets intended user needs in actual use.
• Dimensional inspection of a machined component.
• Traceability mapping of design inputs to outputs.

Correct Answer: Clinical evaluation to confirm the device meets intended user needs in actual use.

Q10. What is the main purpose of verification testing in device development?

• To confirm the device will be accepted by marketing departments.
• To ensure design outputs meet specified design inputs and requirements.
• To evaluate customer satisfaction post-launch.
• To determine the reimbursement code for the device.

Correct Answer: To ensure design outputs meet specified design inputs and requirements.

Q11. When recurring nonconformities are identified from post-market surveillance, which quality system process is used to investigate and prevent recurrence?

• Design transfer
• Change control only
• Corrective and Preventive Action (CAPA)
• Supplier evaluation only

Correct Answer: Corrective and Preventive Action (CAPA)

Q12. What does UDI stand for in medical device regulation?

• Universal Device Index
• Unique Device Identifier
• User Device Information
• Uniform Device Identifier

Correct Answer: Unique Device Identifier

Q13. Which of the following scenarios is considered an adverse event that generally requires reporting to regulatory authorities?

• A device malfunction that did not affect patient outcome and was corrected before use.
• A device malfunction that resulted in serious injury to a patient.
• Routine maintenance activity performed per schedule.
• Marketing complaints about labeling style.

Correct Answer: A device malfunction that resulted in serious injury to a patient.

Q14. Which element is essential to document during a formal validation activity?

• Supplier marketing materials
• Acceptance criteria, test protocols and final validation report
• The color of product packaging
• Only the names of personnel involved, without procedures

Correct Answer: Acceptance criteria, test protocols and final validation report

Q15. In equipment qualification, which stage verifies that equipment performs within established operational ranges?

• Installation Qualification (IQ)
• Design Qualification (DQ)
• Operational Qualification (OQ)
• Maintenance Qualification (MQ)

Correct Answer: Operational Qualification (OQ)

Q16. The US Medical Device Reporting (MDR) regulation that defines mandatory adverse event reporting requirements is found in which CFR part?

• 21 CFR 820
• 21 CFR 11
• 21 CFR 803
• 21 CFR 812

Correct Answer: 21 CFR 803

Q17. What is the primary objective of design transfer in a regulated device lifecycle?

• To move marketing materials to the regulatory affairs team.
• To ensure design outputs are translated into production specifications and manufacturing processes.
• To validate clinical trial endpoints.
• To archive obsolete design documents without review.

Correct Answer: To ensure design outputs are translated into production specifications and manufacturing processes.

Q18. Which EU database is intended to centralize information on medical devices, including vigilance and post-market surveillance data?

• MAUDE
• EUDAMED
• MedWatch
• VigiBase

Correct Answer: EUDAMED

Q19. Which standard series is most relevant for the biological evaluation (biocompatibility) of medical devices?

• ISO 14971
• ISO 10993
• IEC 60601
• IEC 62366

Correct Answer: ISO 10993

Q20. Which activity is not typically considered part of verification?

• Documented bench testing against design specifications.
• Inspection of components to ensure dimensional tolerances.
• Clinical studies to confirm user needs and intended use.
• Software unit and integration testing against requirements.

Correct Answer: Clinical studies to confirm user needs and intended use.

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