BTC Quality Assurance & Standards 2

Question 1

Which FDA regulation governs the quality system requirements for medical device manufacturers in the United States?

Accepted Answer

21 CFR Part 820

Answer

21 CFR Part 820, known as the Quality System Regulation (QSR), sets forth quality system requirements for medical device manufacturers.

Question 2

A biomedical technician discovers that a defibrillator has been repaired using a non-OEM replacement part not listed in the device's approved parts list. The best immediate action is to:

Accepted Answer

Tag the device out of service and notify the supervisor

Answer

Using unapproved parts may violate the manufacturer's specifications and FDA regulations, requiring the device to be removed from service until the issue is resolved.

Question 3

In ISO 9001 quality management, what is the primary purpose of a corrective action?

Accepted Answer

To eliminate the root cause of a nonconformity

Answer

Corrective action targets the root cause of an existing nonconformity to prevent its recurrence, distinguishing it from preventive action.

Question 4

Which of the following best describes 'design validation' in the context of medical device QA?

Accepted Answer

Confirming the device meets user needs under actual or simulated conditions

Answer

Design validation confirms that the finished device meets the intended use requirements under real-world or simulated conditions, including user needs.

Question 5

An incoming inspection program for biomedical equipment should include:

Accepted Answer

Verification of device labeling, safety checks, and performance testing before clinical use

Answer

Incoming inspection must verify labeling accuracy, physical condition, safety parameters, and performance against specifications before any device enters clinical use.

(BTC) Biomedical Technician Certification Practice Test

(BTC) Biomedical Technician Certification Practice Test

BTC Quality Assurance & Standards 2