Medical Device Quality Assurance
( 25 Modules )

Module #1
Introduction to Medical Device Quality Assurance
Overview of medical device quality assurance, importance, and regulatory framework

Module #2
Regulatory Requirements for Medical Devices
Global regulatory requirements, FDA, EU MDR, ISO 13485, and other relevant standards

Module #3
Quality Management System (QMS) Fundamentals
ISO 13485, QMS principles, and requirements for medical device manufacturers

Module #4
Risk Management for Medical Devices
Risk analysis, risk evaluation, and risk control strategies for medical devices

Module #5
Design Control and Design Verification
Design control principles, design inputs, design outputs, and design verification

Module #6
Design Validation and Design Transfer
Design validation, design transfer, and design changes

Module #7
Manufacturing and Process Controls
Manufacturing process controls, production planning, and process validation

Module #8
Material Control and Supply Chain Management
Material control, supplier selection, and supply chain management

Module #9
Sterilization and Packaging Validation
Sterilization methods, packaging validation, and packaging design

Module #10
Labeling and Packaging Controls
Labeling regulations, labeling controls, and packaging labeling

Module #11
Clinical Evaluation and Clinical Trials
Clinical evaluation, clinical trials, and post-market clinical follow-up

Module #12
Medical Device Classification and CE Marking
Medical device classification, CE marking, and EU MDR requirements

Module #13
FDA 510(k) and PMA Submissions
FDA 510(k) and PMA submissions, requirements, and review process

Module #14
Post-Market Surveillance and Vigilance
Post-market surveillance, vigilance, and adverse event reporting

Module #15
Corrective Action and Preventive Action (CAPA)
CAPA principles, root cause analysis, and corrective action implementation

Module #16
Audits and Inspections
Internal audits, external audits, and regulatory inspections

Module #17
Documentation and Record Control
Documentation control, record control, and data management

Module #18
Quality Metrics and Performance Indicators
Quality metrics, performance indicators, and quality dashboard

Module #19
Supply Chain Risk Management
Supply chain risk management, supplier quality, and contract manufacturer management

Module #20
Medical Device Cybersecurity
Medical device cybersecurity, risk management, and regulations

Module #21
Compliance with International Standards
Compliance with international standards, such as ISO 13485, IEC 62304, and others

Module #22
Training and Competency
Training and competency requirements for medical device quality assurance

Module #23
Change Control and Configuration Management
Change control, configuration management, and document control

Module #24
Quality Objectives and Continuous Improvement
Quality objectives, continuous improvement, and quality strategy

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Medical Device Quality Assurance career

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