Title: Explain the application of quality control and the importance of regulatory agencies to the manufacture of biomedical products.
Course: Biomedical Engineering (21049) > Section: Using the Engineering Design Process to Solve a Biomedical Problem

Explanation should include

•    regulatory agencies (e.g., Food and Drug Administration [FDA], U.S. Department of Agriculture [USDA], Federal Communications Commission [FCC], OSHA)
•    quality requirements and standards (e.g., Good Laboratory Practices [GLP], Good Manufacturing Practices [GMP], International Standards Organization [ISO])
•    distinguishing between quality assurance and quality control
•    application of quality control to biomedical products.

Process/Skill Questions:

•    Why are regulatory agencies such as FDA, USDA, FCC, and OSHA concerned with biomedical products?
•    What is the difference between quality control and quality assurance?
•    What are the origins of the guidelines for GLP and GMP?