Certificate in Bio-Medical Devices: Design & Development
-- ViewingNowThe Certificate in Bio-Medical Devices: Design & Development is a comprehensive course that equips learners with essential skills for the rapidly growing bio-medical industry. This program emphasizes the importance of creating safe, effective, and high-quality medical devices that meet regulatory standards.
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โข Introduction to Bio-Medical Devices: Overview, Importance, and Classification
โข Design Principles: Human Factors, Ergonomics, and Usability
โข Regulatory Compliance: FDA, CE Mark, and International Standards
โข Biocompatibility and Material Selection
โข Prototyping and Modeling Techniques: 3D Printing, CAD, and FEA
โข Risk Management: ISO 14971 and Failure Modes and Effects Analysis (FMEA)
โข Clinical Validation: Human Factors Testing, Usability Studies, and Clinical Trials
โข Design Transfer and Manufacturing Processes
โข Quality Assurance and Control: ISO 13485, Six Sigma, and Lean Manufacturing
โข Post-Market Surveillance: Adverse Event Reporting, Recalls, and Market Trends
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