Medical Device Lifecycle Management
( 25 Modules )

Module #1
Introduction to Medical Device Lifecycle Management
Overview of the medical device industry, importance of lifecycle management, and course objectives

Module #2
Regulatory Framework for Medical Devices
Overview of global regulations, FDA, EU MDR, and other regional regulations

Module #3
Design Control and Design Thinking
Design control principles, design thinking, and human-centered design

Module #4
Risk Management and Hazard Analysis
Risk management principles, hazard analysis, and mitigation strategies

Module #5
Verification and Validation
Verification and validation principles, testing, and validation methods

Module #6
Clinical Evaluation and Clinical Trials
Clinical evaluation, clinical trial design, and clinical trial conduct

Module #7
Device Classification and CE Marking
Device classification, CE marking, and EU MDR requirements

Module #8
Labeling and Packaging
Labeling and packaging requirements, UDI, and labeling regulations

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

Module #10
Manufacturing and Quality Control
Manufacturing principles, quality control, and quality management systems

Module #11
Supply Chain Management and Supplier Quality
Supply chain management, supplier quality, and supplier selection

Module #12
Post-Market Surveillance and Vigilance
Post-market surveillance, vigilance, and adverse event reporting

Module #13
Corrective Action and Preventive Action (CAPA)
CAPA principles, corrective action, and preventive action

Module #14
Medical Device Recalls and Field Actions
Recall principles, field actions, and recall management

Module #15
FDA Inspections and Audits
FDA inspections, audits, and compliance

Module #16
ISO 13485 and Quality Management Systems
ISO 13485 requirements, quality management systems, and certification

Module #17
Medical Device Software and Cybersecurity
Medical device software, cybersecurity, and software validation

Module #18
Electromagnetic Compatibility (EMC) and Safety
EMC principles, safety requirements, and EMC testing

Module #19
Environmental and Sustainability Considerations
Environmental impact, sustainability, and eco-design principles

Module #20
Global Regulatory Requirements and Harmonization
Global regulatory requirements, harmonization, and international standards

Module #21
Medical Device Standards and Guidelines
Medical device standards, guidelines, and industry best practices

Module #22
Medical Device Lifecycle Management Tools and Technologies
MDLM tools, technologies, and digital transformation

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

Module #24
Training and Competency for Medical Device Professionals
Training and competency requirements, professional development, and certification

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

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Medical Device Lifecycle Management ( 25 Modules )

Medical Device Lifecycle Management
( 25 Modules )