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

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Risk Management and Quality Assurance in Medical Devices ( 25 Modules )

Risk Management and Quality Assurance in Medical Devices
( 25 Modules )