Curriculum
- 1 Section
- 9 Lessons
- 40 Hours
Expand all sectionsCollapse all sections
- 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.
Requirements
- Experience:
Five years of work experience in biomedical auditing, with at least one year in a decision-making role. - Education Waivers:
Associate’s Degree: One year of experience waived.
Bachelor’s Degree: Three years of experience waived.
Master’s or Doctorate Degree: Four years of experience waived.
Target audiences
- Biomedical Auditors
- Biomedical Engineers
- Project Managers
- Quality Audit Managers
- Quality Engineers
- Quality Managers
- Regulatory Experts
- Supplier Quality Engineers