Q: Develop strategies for customizing quality management system (QMS) to particular companies, biomedical products, and manufacturing environments based on the FDA’s expectations for product design control, quality system documentation, and practical manufacturing principles.

Statement 1: Define the role of compliance in regulated industries and regulatory decision making

Statement 2: Demonstrate an understanding of the scientific, technological and engineering principles required to work in regulated industries, including healthcare through successful completion of quantitatively oriented Problem Sets

Statement 3: Explain how fundamental compliance principles are applied in professional practice through analysis of a current healthcare issue from a regulatory perspective.

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