TENNESSEE MEDICAL DEVICE COMPLIANCE AUDITOR EXAM – EXAM PRACTICE
QUESTIONS AND CORRECT ANSWERS (VERIFIED ANSWERS) PLUS RATIONALES 2026
Q&A | INSTANT DOWNLOAD PDF
CORE DOMAINS
Medical Device Regulatory Compliance (FDA 21 CFR Part 820)
ISO 13485 Quality Management Systems
Good Manufacturing Practices (GMP)
Risk Management (ISO 14971)
Internal & External Audit Procedures
Documentation Control Systems
Corrective and Preventive Actions (CAPA)
Medical Device Reporting (MDR) Requirements
Supplier Quality Management
Ethical & Professional Audit Standards
,INTRODUCTION
This examination assesses the knowledge and applied competencies required for a Medical
Device Compliance Auditor responsible for evaluating manufacturing systems, quality
management programs, and regulatory adherence within medical device organizations. It
measures understanding of international and U.S. regulatory frameworks, audit planning
and execution, documentation review, risk-based thinking, and corrective action processes.
The exam includes multiple-choice and scenario-based questions designed to reflect real-
world auditing situations. Candidates are expected to demonstrate analytical thinking,
regulatory interpretation skills, and the ability to identify nonconformities and recommend
compliant corrective actions in professional environments.
SECTION ONE: QUESTIONS 1–50
1. What is the primary purpose of FDA 21 CFR Part 820?
A. To regulate pharmaceutical pricing
B. To establish quality system requirements for medical devices
,C. To control hospital accreditation standards
D. To define clinical trial protocols
🟢 Correct Answer: B. To establish quality system requirements for medical devices
🔴 Explanation: FDA 21 CFR Part 820 outlines the Quality System Regulation (QSR)
requirements for medical device manufacturers to ensure devices are safe and effective.
2. Which ISO standard is most commonly associated with medical device quality
management systems?
A. ISO 9001
B. ISO 14001
C. ISO 13485
D. ISO 27001
🟢 Correct Answer: C. ISO 13485
🔴 Explanation: ISO 13485 specifically defines requirements for quality management
systems in the medical device industry.
3. What is the first step in conducting a compliance audit?
, A. Issuing corrective actions
B. Preparing the audit plan
C. Closing nonconformities
D. Reviewing CAPA records only
🟢 Correct Answer: B. Preparing the audit plan
🔴 Explanation: Audit planning establishes scope, objectives, and criteria before fieldwork
begins.
4. Which document defines the scope of a quality management system audit?
A. Audit report
B. Audit checklist
C. Audit plan
D. CAPA form
🟢 Correct Answer: C. Audit plan
🔴 Explanation: The audit plan outlines scope, processes, and areas to be reviewed.
5. A nonconformity is best defined as:
QUESTIONS AND CORRECT ANSWERS (VERIFIED ANSWERS) PLUS RATIONALES 2026
Q&A | INSTANT DOWNLOAD PDF
CORE DOMAINS
Medical Device Regulatory Compliance (FDA 21 CFR Part 820)
ISO 13485 Quality Management Systems
Good Manufacturing Practices (GMP)
Risk Management (ISO 14971)
Internal & External Audit Procedures
Documentation Control Systems
Corrective and Preventive Actions (CAPA)
Medical Device Reporting (MDR) Requirements
Supplier Quality Management
Ethical & Professional Audit Standards
,INTRODUCTION
This examination assesses the knowledge and applied competencies required for a Medical
Device Compliance Auditor responsible for evaluating manufacturing systems, quality
management programs, and regulatory adherence within medical device organizations. It
measures understanding of international and U.S. regulatory frameworks, audit planning
and execution, documentation review, risk-based thinking, and corrective action processes.
The exam includes multiple-choice and scenario-based questions designed to reflect real-
world auditing situations. Candidates are expected to demonstrate analytical thinking,
regulatory interpretation skills, and the ability to identify nonconformities and recommend
compliant corrective actions in professional environments.
SECTION ONE: QUESTIONS 1–50
1. What is the primary purpose of FDA 21 CFR Part 820?
A. To regulate pharmaceutical pricing
B. To establish quality system requirements for medical devices
,C. To control hospital accreditation standards
D. To define clinical trial protocols
🟢 Correct Answer: B. To establish quality system requirements for medical devices
🔴 Explanation: FDA 21 CFR Part 820 outlines the Quality System Regulation (QSR)
requirements for medical device manufacturers to ensure devices are safe and effective.
2. Which ISO standard is most commonly associated with medical device quality
management systems?
A. ISO 9001
B. ISO 14001
C. ISO 13485
D. ISO 27001
🟢 Correct Answer: C. ISO 13485
🔴 Explanation: ISO 13485 specifically defines requirements for quality management
systems in the medical device industry.
3. What is the first step in conducting a compliance audit?
, A. Issuing corrective actions
B. Preparing the audit plan
C. Closing nonconformities
D. Reviewing CAPA records only
🟢 Correct Answer: B. Preparing the audit plan
🔴 Explanation: Audit planning establishes scope, objectives, and criteria before fieldwork
begins.
4. Which document defines the scope of a quality management system audit?
A. Audit report
B. Audit checklist
C. Audit plan
D. CAPA form
🟢 Correct Answer: C. Audit plan
🔴 Explanation: The audit plan outlines scope, processes, and areas to be reviewed.
5. A nonconformity is best defined as:
