Biomedical Auditor Regulatory Compliance Flashcards
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Read the first 6 Biomedical Auditor Regulatory Compliance flashcards as text
Which U.S. regulation governs the safety and effectiveness of medical devices?
Answer: 21 CFR Part 820
The FDA’s 21 CFR Part 820 outlines quality system requirements for medical device manufacturers to ensure safety and compliance.
What is the role of a regulatory audit?
Answer: To verify compliance with regulatory standards
Regulatory audits assess compliance with laws and standards, ensuring biomedical organizations follow required procedures.
What does ISO 13485 focus on?
Answer: Medical device quality management
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services.
Why is regulatory compliance critical in biomedical auditing?
Answer: It ensures patient safety and legal adherence
Compliance ensures patient safety, reduces legal risks, and enhances public trust in medical products and practices.
Which agency is responsible for medical device approval in the United States?
Answer: FDA
The FDA evaluates and approves medical devices before they reach the market to ensure they are safe and effective.
What is a common consequence of regulatory noncompliance?
Answer: Fines, recalls, or certification loss
Noncompliance may lead to fines, legal penalties, product recalls, or loss of certifications, damaging an organization's reputation and operations.