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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