Advanced Techniques in Medical Device Quality Control
( 25 Modules )

Module #1
Introduction to Medical Device Quality Control
Overview of medical device regulations, importance of quality control, and course objectives

Module #2
Risk Management in Medical Devices
Understanding risk management principles, risk analysis, and mitigation strategies

Module #3
ISO 13485:2016 - Medical Device Quality Management System
Overview of ISO 13485, quality management principles, and implementation guidelines

Module #4
Design Control and Design Verification
Design control principles, design verification, and validation methods

Module #5
Material Science and Properties in Medical Devices
Understanding material properties, selection, and testing for medical devices

Module #6
Sterilization and Packaging Validation
Sterilization methods, packaging validation, and regulatory requirements

Module #7
Biocompatibility Testing and Evaluation
Biocompatibility principles, testing methods, and regulatory requirements

Module #8
Electrical Safety and Performance Testing
Electrical safety principles, performance testing, and IEC 60601-1 standards

Module #9
Stability and Shelf Life of Medical Devices
Stability testing, shelf life determination, and label claim verification

Module #10
Auditing and Root Cause Analysis
Auditing principles, root cause analysis, and corrective action methods

Module #11
Corrective Action and Preventive Action (CAPA)
CAPA principles, implementation, and best practices

Module #12
Validation and Verification of Computerized Systems
Validation and verification of computerized systems, software, and data systems

Module #13
Medical Device Cybersecurity
Medical device cybersecurity risks, threats, and mitigation strategies

Module #14
Supply Chain Risk Management
Supply chain risk management principles, supplier selection, and-outsourcing

Module #15
Regulatory Requirements for Medical Devices
Overview of FDA, EU MDR, and other regulatory requirements for medical devices

Module #16
Post-Market Surveillance and Vigilance
Post-market surveillance, vigilance, and adverse event reporting

Module #17
Medical Device Recalls and Corrective Actions
Recall policies, procedures, and best practices for medical devices

Module #18
Advanced Statistical Process Control
Applications of statistical process control in medical device manufacturing

Module #19
Machine Learning and Artificial Intelligence in Medical Devices
Applications of machine learning and AI in medical devices, regulatory considerations

Module #20
Additive Manufacturing and 3D Printing in Medical Devices
Applications, benefits, and challenges of additive manufacturing in medical devices

Module #21
Nanotechnology in Medical Devices
Applications, benefits, and challenges of nanotechnology in medical devices

Module #22
Medical Device Software Development and Validation
Software development life cycle, validation, and regulatory requirements

Module #23
Risk-Based Quality Management in Medical Devices
Risk-based quality management principles, implementation, and best practices

Module #24
Quality Metrics and Performance Indicators
Quality metrics, performance indicators, and data-driven decision making

Module #25
Course Wrap-Up & Conclusion
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Advanced Techniques in Medical Device Quality Control ( 25 Modules )

Advanced Techniques in Medical Device Quality Control
( 25 Modules )