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Free CMDA Practice Questions

10 free, exam-style Certified Medical Device Auditor (CMDA) practice questions with answers and explanations. No signup required. Work through them below, then take the full free CMDA practice test to study every exam domain.

Question 1

A medical device manufacturer sends its own quality engineers to audit a contract facility that provides sterilization services for the manufacturer's products. This audit is BEST classified as a:

  1. Second-party audit
  2. First-party audit
  3. Third-party audit
  4. Surveillance audit performed on behalf of a notified body
Show answer & explanation

Correct answer: A - Second-party audit

Question 2

An auditor confirms that a production technician records each test result in the device history record at the moment the test is completed, rather than batching the entries at the end of the shift. Which data integrity principle does this practice MOST directly support?

  1. Attributable
  2. Legible
  3. Original
  4. Contemporaneous
Show answer & explanation

Correct answer: D - Contemporaneous

Question 3

An auditor selects a finished device from the shipping dock and follows its records back through final inspection, assembly, and incoming component acceptance. This audit strategy is known as:

  1. Forward tracing
  2. Discovery sampling
  3. Backward tracing
  4. Process flow analysis
Show answer & explanation

Correct answer: C - Backward tracing

Question 4

Within design controls, what is the PRIMARY distinction between design verification and design validation?

  1. Verification is conducted by the supplier; validation is conducted by the manufacturing site
  2. Verification applies only to Class III devices; validation applies to every device class
  3. Verification confirms outputs meet inputs; validation confirms the device meets user needs
  4. Verification assesses the manufacturing process; validation assesses the device's final packaging
Show answer & explanation

Correct answer: C - Verification confirms outputs meet inputs; validation confirms the device meets user needs

Question 5

During an audit, the auditor wants to confirm that one specific finished lot of devices was actually manufactured and tested in accordance with its approved specifications. Which record should the auditor request?

  1. Device History Record (DHR)
  2. Device Master Record (DMR)
  3. Design History File (DHF)
  4. Technical documentation file
Show answer & explanation

Correct answer: A - Device History Record (DHR)

Question 6

A manufacturer identifies a nonconforming lot, reworks the affected units to bring them back into specification, and releases them - without investigating why the nonconformance occurred. This response is BEST described as a:

  1. Corrective action
  2. Correction
  3. Preventive action
  4. Containment of a systemic deficiency
Show answer & explanation

Correct answer: B - Correction

Question 7

According to ISO 14971, risk is defined as the combination of which two elements?

  1. The probability of occurrence of harm and its severity
  2. The severity of harm and the ability to detect the harm
  3. The probability of a hazard and the cost of mitigating it
  4. The frequency of device use and the complexity of the device
Show answer & explanation

Correct answer: A - The probability of occurrence of harm and its severity

Question 8

A terminally sterilized medical device is validated to a Sterility Assurance Level (SAL) of 10⁻⁶. What does this value represent?

  1. Each device is permitted to contain up to one million microorganisms
  2. At least 99.9999 percent of microorganisms present are removed during the cleaning step before packaging
  3. The device must be removed from the market and re-sterilized after one million uses
  4. The probability of a single viable microorganism surviving on a device is one in one million
Show answer & explanation

Correct answer: D - The probability of a single viable microorganism surviving on a device is one in one million

Question 9

Under IEC 62304, a medical device software component is assigned to safety Class C. This classification indicates that a failure of the software could:

  1. Result in no possible injury or damage to health
  2. Result in death or serious injury
  3. Result in non-serious injury
  4. Affect only non-clinical administrative functions
Show answer & explanation

Correct answer: B - Result in death or serious injury

Question 10

In acceptance sampling, the risk that a sampling plan will accept a lot that actually fails to meet the quality requirement is known as:

  1. Producer's risk (alpha)
  2. Detection risk
  3. Consumer's risk (beta)
  4. Sampling error
Show answer & explanation

Correct answer: C - Consumer's risk (beta)

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