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
