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- CBA® Certified Biomedical Auditor
Curriculum
- 1 Section
- 9 Lessons
- 40 Hours
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- CONTENT:9
- 1.1Introduction: Overview of auditing principles and practices.
- 1.2Audit Types and Roles: Different audit methodologies and ethical considerations.
- 1.3Biomedical Quality Management: Requirements and regulations.
- 1.4Quality Tools and Techniques: Pareto charts, SPC, flowcharts, and more.
- 1.5Risk Management: Standards and practices for risk evaluation.
- 1.6Regulatory Compliance: FDA regulations, ISO standards, and quality systems.
- 1.7Biocompatibility and Validation: Testing and environmental controls.
- 1.8Software and Quality Systems: Understanding the software development life cycle.
- 1.9Case Studies and Practical Exercises: Real-world scenarios and applications.