Practice Test Geeks(CPMS) Certified Professional for Medical Software Practice Test
← All CPMS Flashcard Decks

CPMS Risk Management & Quality Assurance Flashcards

6 cards from real CPMS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 CPMS Risk Management & Quality Assurance flashcards as text

  1. What is the difference between 'risk' and 'hazard' in ISO 14971 terminology?

    Answer: A hazard is a potential source of harm; risk is the combination of probability of harm and its severity

    In ISO 14971, a hazard is a potential source of harm, while risk is defined as the combination of the probability that harm occurs and the severity of that harm.

  2. What is 'residual risk' in medical device risk management?

    Answer: The risk remaining after risk control measures have been implemented

    Residual risk is the risk that remains after all risk control measures have been applied and must be evaluated to determine overall acceptability.

  3. In medical software quality assurance, what does 'design review' accomplish?

    Answer: It provides systematic examination of design outputs to ensure requirements are met and defects are identified early

    Design reviews are formal, systematic examinations of design outputs that identify deficiencies early and confirm that design requirements are being met.

  4. What is the purpose of a Risk/Benefit analysis in ISO 14971?

    Answer: To evaluate whether the expected clinical benefits of a device outweigh its risks to justify its use

    Risk/benefit analysis determines whether the expected clinical benefits of the medical device outweigh the residual risks, justifying the device's availability to patients.

  5. Which FDA regulation requires medical device manufacturers to establish and maintain a Design History File (DHF)?

    Answer: 21 CFR Part 820.30

    21 CFR Part 820.30 requires manufacturers to establish and maintain a Design History File that records the design controls history for each type of device.

  6. In medical software risk management, what is a 'fault tree analysis' (FTA) used for?

    Answer: Identifying combinations of events and failures that could lead to an undesired top-level event or hazard

    FTA is a top-down, deductive analysis that identifies combinations of events and failures that could lead to a specific undesired hazardous event.