Medical Device Regulation and Compliance
( 30 Modules )

Module #1
Introduction to Medical Device Regulation
Overview of the medical device industry, importance of regulation, and global regulatory landscape

Module #2
FDA Regulatory Framework
History and organization of the FDA, device classification, and regulatory pathways (510(k), PMA, HDE)

Module #3
EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
Overview of the MDR and IVDR, key changes, and impact on industry

Module #4
Risk Management and Hazard Analysis
Principles of risk management, hazard analysis, and risk assessment for medical devices

Module #5
Design Controls and Design Verification
Design control principles, design input, design output, and design verification

Module #6
Manufacturing Controls and Process Validation
Manufacturing control principles, process validation, and quality system regulations

Module #7
Labeling and Advertising Regulations
Labeling requirements, advertising regulations, and promotion of medical devices

Module #8
Clinical Trials and Study Design
Clinical trial design, conduct, and reporting for medical devices

Module #9
Premarket Submissions and Approvals
Premarket submission requirements, FDA review process, and approval/ clearance decisions

Module #10
Postmarket Surveillance and Vigilance
Postmarket surveillance, vigilance reporting, and corrective action

Module #11
Compliance and Enforcement
FDA inspections, compliance program, and enforcement actions

Module #12
Quality System Regulation (QSR) and ISO 13485
Overview of QSR and ISO 13485, quality system requirements, and certificationprocess

Module #13
Medical Device Classification and Coding
Device classification, FDA product codes, and ICD-10 coding

Module #14
Supply Chain and Vendor Management
Supply chain management, vendor selection, and vendor control

Module #15
Sterilization and Packaging
Sterilization methods, packaging requirements, and labeling for sterile devices

Module #16
Software and Cybersecurity for Medical Devices
Software development, cybersecurity risks, and regulatory requirements

Module #17
Electromagnetic Compatibility (EMC) and Electrical Safety
EMC principles, electrical safety requirements, and testing for medical devices

Module #18
Global Harmonization and Regional Regulations
Global harmonization efforts, regional regulations (e.g., Canada, Japan, Australia), and international standards

Module #19
Combination Products and borderline Products
Combination products, borderline products, and regulatory pathways

Module #20
Medical Device Reporting (MDR) and Vigilance Reporting
MDR requirements, reporting, and vigilance reporting for medical devices

Module #21
Regulatory Strategy and Planning
Developing a regulatory strategy, planning, and project management for medical device development

Module #22
Regulatory Affairs and Compliance Career Development
Career paths in regulatory affairs, professional development, and industry trends

Module #23
Case Studies in Medical Device Regulation
Real-world case studies of medical device regulation, compliance, and regulatory challenges

Module #24
FDA Inspections and Audits
Preparation for FDA inspections, audit process, and responding to 483s and warning letters

Module #25
Corrective Action and Preventive Action (CAPA)
CAPA principles, implementation, and effectiveness for medical devices

Module #26
Medical Device Standards and Guidance
Overview of medical device standards, guidance documents, and industry standards

Module #27
Regulatory Intelligence and Monitoring
Regulatory intelligence, monitoring, and staying current with global regulatory changes

Module #28
Medical Device Labeling and Instructions for Use
Labeling requirements, instructions for use, and user documentation for medical devices

Module #29
Medical Device Servicing and Refurbishment
Regulatory requirements, servicing, and refurbishment of medical devices

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Medical Device Regulation and Compliance career

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Medical Device Regulation and Compliance ( 30 Modules )

Medical Device Regulation and Compliance
( 30 Modules )