Medical Device Design MCQ

Q1. Which agency is primarily responsible for medical device regulation in the USA?

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Q2. Medical devices are classified based on:

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Q3. Which of the following is a Class III medical device?

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Q4. What does IEC 60601 standard refer to?

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Q5. Design controls in medical device development include:

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Q6. Usability engineering in medical devices focuses on:

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Q7. ISO 13485 standard addresses:

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Q8. Risk management in medical device design is guided by:

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Q9. Which biomaterial is commonly used in orthopedic implants?

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Q10. The purpose of validation in medical device development is:

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Q11. CE marking on a medical device indicates:

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Q12. Life cycle model commonly used in medical devices is:

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Q13. Main consideration in selecting implant materials is:

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Q14. FDA 510(k) process requires:

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Q15. Good device user manual includes:

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Q16. Which is an example of diagnostic device?

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Q17. Design verification checks whether:

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Q18. Clinical evaluation in devices involves:

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Q19. Definition of biomaterial:

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Q20. Challenge in medical device design includes:

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Q21. Sterilization means:

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Q22. Medical implant power source is usually:

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Q23. Ergonomics in device design focuses on:

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Q24. Wireless patient monitoring uses:

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Q25. Risk management in device development aims:

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Q26. Software specialization key for medical devices:

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Q27. Software standard for medical devices:

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Q28. First development stage is:

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Q29. Materials not used in medical devices:

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Q30. FDA approval requires:

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Q31. Biocompatibility means:

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Q32. Example of dialysis device:

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Q33. Medical imaging method using X-rays:

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Q34. Clinical engineer job:

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Q35. Clinical engineer role:

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