Biomedical Auditor Regulatory Compliance

Question 1

Which U.S. regulation governs the safety and effectiveness of medical devices?

Accepted Answer

21 CFR Part 820

Answer

OSHA Act

Answer

HIPAA

Answer

Sarbanes-Oxley Act

Question 2

What is the role of a regulatory audit?

Accepted Answer

To verify compliance with regulatory standards

Answer

To evaluate marketing strategy

Answer

To increase investor confidence

Answer

To assess employee performance

Question 3

What does ISO 13485 focus on?

Accepted Answer

Medical device quality management

Answer

Software development standards

Answer

Environmental controls

Answer

Clinical trial registration

Question 4

Why is regulatory compliance critical in biomedical auditing?

Accepted Answer

It ensures patient safety and legal adherence

Answer

It accelerates production cycles

Answer

It boosts marketing results

Answer

It reduces audit costs

Question 5

Which agency is responsible for medical device approval in the United States?

Accepted Answer

FDA

Answer

CDC

Answer

EPA

Answer

FTC

Question 6

What is a common consequence of regulatory noncompliance?

Accepted Answer

Fines, recalls, or certification loss

Answer

Employee bonuses

Answer

Increased market share

Answer

Higher production efficiency