Risk Management and Quality Assurance in Medical Devices
( 25 Modules )
Module #1 Introduction to Medical Device Regulation Overview of the medical device industry, regulations, and standards
Module #2 Risk Management Fundamentals Introduction to risk management principles, definitions, and standards
Module #3 Risk Management throughout the Product Lifecycle Understanding risk management during design, production, distribution, and post-market surveillance
Module #4 Quality Management System (QMS) Overview Introduction to QMS, ISO 13485, and quality principles
Module #5 Quality Management System Audit and Surveillance Auditing and surveillance of QMS, ISO 13485 requirements
Module #6 Device Classification and Regulatory Pathways Understanding device classification, regulatory pathways, and submission requirements
Module #7 Design Controls and Design Verification Design controls, design verification, and validation principles
Module #8 Risk Analysis and Evaluation Conducting risk analysis, evaluating risk, and prioritization techniques
Module #9 Risk Mitigation and Control Developing and implementing risk mitigation and control strategies
Module #10 FMEA (Failure Mode and Effects Analysis) Understanding and applying FMEA to medical devices
Module #11 Hazard Analysis and Critical Control Points (HACCP) Understanding and applying HACCP to medical devices
Module #12 Quality Risk Management and Phased Risk Management Applying quality risk management and phased risk management to medical devices
Module #13 CAPA (Corrective and Preventive Action) and Nonconformance Management Understanding and implementing CAPA and nonconformance management processes
Module #14 Complaint Handling and Medical Device Reporting Understanding and implementing complaint handling and medical device reporting processes
Module #15 Post-Market Surveillance and Vigilance Understanding and implementing post-market surveillance and vigilance activities
Module #16 Device Sterilization and Cleaning Validation Understanding sterilization and cleaning validation principles and regulations
Module #17 Packaging and Labeling Regulations Understanding packaging and labeling regulations for medical devices
Module #18 Medical Device Software and Cybersecurity Understanding software and cybersecurity regulations and guidelines for medical devices
Module #19 Clinical Evaluation and Clinical Trials Understanding clinical evaluation and clinical trials requirements for medical devices
Module #20 Regulatory Submissions and Approvals Preparing and submitting regulatory submissions for medical device approvals
Module #21 Auditing and Inspections Understanding auditing and inspection principles, ISO 13485, and regulatory requirements
Module #22 Quality Metrics and Performance Indicators Developing and using quality metrics and performance indicators for medical devices
Module #23 Continuous Improvement and Quality Optimization Implementing continuous improvement and quality optimization principles for medical devices
Module #24 Risk Management in Medical Device Development Applying risk management principles to medical device development and design
Module #25 Course Wrap-Up & Conclusion Planning next steps in Risk Management and Quality Assurance in Medical Devices career
