Quiz · MDR 1/1

Medical Device Reporting Awareness

10 questions80% to pass

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1Which regulation addresses MDR?Choose one

21 CFR Part 820 only 21 CFR Part 803 ISO 9000 clause 3 alone The Google Forms quiz settings

2Which event may require manufacturer reporting even without an actual injury?Choose one

Every cosmetic observation regardless of effect Every request for an extra instruction manual Every shipping delay unrelated to device performance A malfunction likely to cause death or serious injury if it recurred

3What is the relevant causation threshold described in this lesson?Choose one

Information reasonably suggesting the device may have caused or contributed A final court finding that the device caused the event Completion of every possible technical test Agreement by both patient and manufacturer on the root cause

4What is the standard manufacturer MDR reporting period taught here?Choose one

Within 30 work days of finishing the investigation Within 5 calendar days for every complaint Within 30 calendar days of awareness of a reportable event At the next annual management review

5Which circumstance can trigger a five-work-day report?Choose one

Any complaint with an unanswered phone call Remedial action needed to prevent an unreasonable risk of substantial harm to public health Any product returned during warranty Any planned procedure revision

6A concerning event is under technical investigation. What should the Quality Manager do?Choose one

Promptly involve the reporting lead and preserve the available evidence Wait for final root cause before notifying the reporting lead Assume it is not reportable until a test reproduces the failure Use the full standard reporting period before escalating internally

7A patient submitted a voluntary MedWatch report. What does that mean for the manufacturer?Choose one

The manufacturer’s reporting duty is automatically satisfied No manufacturer complaint record is needed The manufacturer must wait for FDA to contact it Its own applicable reporting duties still need assessment

8What should be captured when a potentially reportable event is received?Choose one

Only the final investigation conclusion Only a count for the next annual review The available event details, device identity and timing of receipt Only the customer’s preferred remedy

9What does an MDR in MAUDE establish by itself?Choose one

That an event was reported, not that causation has been proven That the device definitely caused the outcome That the device has a higher failure rate than every competitor That FDA has ordered a recall

10Why should raw MAUDE counts not be used to compare device adverse-event rates?Choose one

Because the database contains only premarket tests Because reports are never useful for safety review Reporting limitations and unknown exposure can make the rates indeterminable Because all devices have exactly the same exposure