Podcast
Questions and Answers
Which regulation incorporates design controls into the Quality System Regulation?
Which regulation incorporates design controls into the Quality System Regulation?
- ISO 9001
- FDA 21 CFR 820.30
- Food and Drug Administration
- Current Good Manufacturing Practice (CGMP) (correct)
What is the purpose of the design control framework established by the regulation?
What is the purpose of the design control framework established by the regulation?
- To prescribe specific design practices for medical devices
- To regulate the development and implementation of medical devices
- To provide flexibility for manufacturers in developing design controls (correct)
- To ensure consistency in quality assurance practices
What is the relationship between ISO 9001 and FDA 21 CFR 820.30?
What is the relationship between ISO 9001 and FDA 21 CFR 820.30?
- ISO 9001 is a worldwide quality system requirement
- ISO 9001 is a component of FDA 21 CFR 820.30 (correct)
- ISO 9001 is a revision of FDA 21 CFR 820.30
- ISO 9001 is a framework for developing design controls
What is the purpose of the Center for Devices and Radiological Health?
What is the purpose of the Center for Devices and Radiological Health?
What does the regulation prescribe for the practices that must be used for design controls?
What does the regulation prescribe for the practices that must be used for design controls?
Which regulatory requirement includes design controls for medical device manufacturers?
Which regulatory requirement includes design controls for medical device manufacturers?
What is the purpose of the design control framework established by the regulation?
What is the purpose of the design control framework established by the regulation?
What does the regulation require manufacturers to do when developing and implementing design controls?
What does the regulation require manufacturers to do when developing and implementing design controls?
What is the relationship between FDA 21 CFR 820.30 and ISO 9001?
What is the relationship between FDA 21 CFR 820.30 and ISO 9001?
What is the purpose of the Center for Devices and Radiological Health?
What is the purpose of the Center for Devices and Radiological Health?
Flashcards are hidden until you start studying
