1. ISO 13485 requires medical device manufacturers to define and apply documented methods for monitoring and measuring production processes, including the use of valid statistical techniques for ensuring product conformity.

2. In acceptance sampling for production, the Acceptable Quality Level (AQL) represents the maximum number of defects allowed in a sample above which the entire lot would be rejected.

3. Control charts with 3-sigma limits capture approximately 99.73% of common cause variation in a stable process.

4. For clinical trials of medical devices, a statistical power of 60% is considered adequate by regulatory guidelines.

5. In process validation for medical devices, Cp and Cpk indices are used to assess process capability and centering respectively.

6. Double sampling plans always require a larger total sample size than single sampling plans.

7. In clinical trials for medical device, one-sided statistical tests should use α = 0.05 for consistency

8. Variables sampling typically requires larger sample sizes than attributes sampling to achieve the same level of statistical confidence.

9. Continued Process Verification (CPV) is the third stage of process validation and typically uses statistical process control methods.

10. Type I error (α) represents the probability of accepting a bad lot or ineffective treatment.

1. What is the primary purpose of Statistical Process Control (SPC) in medical device manufacturing?

2. In acceptance sampling for medical devices, what does the sample size "n" determine?

3. Which situation requires process validation under ISO 13485?

4. Which control chart is most appropriate for monitoring the number of defects with constant sample size in medical device production?

5. In process capability analysis, what does a Cpk value of 1.33 indicate?

6. Which statistical tool is most commonly used to monitor continuous data, such as dimensional measurements, in a medical device manufacturing process?

7. In sample size calculation for medical device studies, which factor does NOT typically influence the required sample size?

8. What does AQL stand for in quality control?

9. In a control chart, points falling outside the control limits indicate:

10. Which sampling standard is commonly used for attribute sampling in medical device manufacturing?

11. What does "power" represent in statistics for medical device?

12. What is the primary difference between variables and attributes sampling?

13. In process validation, what does IQ/OQ/PQ stand for?

14. For sterilization validation of medical devices, what statistical confidence level is typically required?

15. In Design of Experiments (DOE) for medical device development, what is a 'factor'?

16. What does LTPD stand for in acceptance sampling?

17. Which type of data is best analyzed with a Chi-square test in a medical device quality improvement project?

18. In statistical process control, what does a 'run' of 7 consecutive points on one side of the centerline indicate?

19. Which statement best describes the meaning of "control limits" on a control chart used in medical device manufacturing?

20. In risk-based statistical sampling for process validation, what should primarily determine the sample size?