Medical Device Design MCQ

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

Q2. Medical devices are classified based on:

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

Q4. What does IEC 60601 standard refer to?

Q5. Design controls in medical device development include:

Q6. Usability engineering in medical devices focuses on:

Q7. ISO 13485 standard addresses:

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

Q9. Which biomaterial is commonly used in orthopedic implants?

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

Q11. CE marking on a medical device indicates:

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

Q13. Main consideration in selecting implant materials is:

Q14. FDA 510(k) process requires:

Q15. Good device user manual includes:

Q16. Which is an example of diagnostic device?

Q17. Design verification checks whether:

Q18. Clinical evaluation in devices involves:

Q19. Definition of biomaterial:

Q20. Challenge in medical device design includes:

Q21. Sterilization means:

Q22. Medical implant power source is usually:

Q23. Ergonomics in device design focuses on:

Q24. Wireless patient monitoring uses:

Q25. Risk management in device development aims:

Q26. Software specialization key for medical devices:

Q27. Software standard for medical devices:

Q28. First development stage is:

Q29. Materials not used in medical devices:

Q30. FDA approval requires:

Q31. Biocompatibility means:

Q32. Example of dialysis device:

Q33. Medical imaging method using X-rays:

Q34. Clinical engineer job:

Q35. Clinical engineer role:

Q36. ISO 14971 relates to:

Q37. Medical oxygen saturation measured by:

Q38. Ultrasound probes use:

Q39. Medical device software development requirement:

Q40. Medical device label must include: