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Oct 23, 2026
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BMED 2300 - Introduction to Quality Assurance
Credits: 3
Catalog Description
This course will provide students with an in-depth understanding of the role quality plays in an industrial environment regulated by the Food and Drug Administration (FDA). The course will cover the responsibilities of quality assurance during the engineering, manufacturing, and production of a product. Topics will include management responsibilities, design control, production and process controls, continuous improvement, and methods and tools used to support quality assurance. The ISO standards, the regulatory requirements mandated by the FDA, and the European Medical Devices Directive (MDD), are also covered.
Additional fee to student: No
Learner Outcomes
- Demonstrate an understanding of the similarities and differences between the Food and Drug Administration (FDA) regulations governing Medical Device manufacturers, the ISO 9000 standards, and European Medical Devices Directive (MDD).
- Demonstrate an understanding of the organizational entities that comprise a quality organization in a medical device manufacturing firm.
- Demonstrate an understanding of the concepts of quality.
- Demonstrate an understanding of the concept of design controls as it relates to product quality.
- Demonstrate an understanding of the concept of production and process controls as it relates to product quality.
- Demonstrate an understanding of management responsibilities as they relate to product quality.
- Demonstrate an understanding of the role of corrective and preventative actions as it relates to continuous improvement.
- Demonstrate an understanding of the methods and tools used to control quality.
Major Areas of Course Content
These areas should be covered by everyone teaching this course.
- CONCEPTS OF QUALITY ASSURANCE
- Basic Concepts
- Traditional Versus Total
- Approaches
- Characteristics
- Organizational Responsibilities
- REGULATIONS AND STANDARDS
- FDA History
- FDA Regulations
- ISO History
- ISO and FDA Regulatory Requirements
- European Union Medical Device Directives (MDD)
- Global Harmonization Task Force GHTF)
- Quality System Inspection Technique (QSIT)
- QUALITY ORGANIZATION
- DESIGN CONTROL
- FDA Quality System Regulation (QSR) 820.30 Design Control Elements
- Traceability
- Risk/Hazard Analysis
- Design Control
- PRODUCTION AND PROCESS CONTROLS
- MANAGEMENT·RESPONSIBILITIES
- CORRECTIVE AND PREVENTATIVE ACTION
- FDA QSR 820.100 Corrective and Preventative Action (CAPA)
- Data Sources
- CAPA Systems
- TOOLS AND METHODS
Credit for Prior Learning Options
No credit for prior learning option is available for this course.
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