Global Medical Device Regulatory Requirements
( 25 Modules )

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

Module #2
Global Regulatory Framework
Comparison of regulatory frameworks in major markets (US, EU, Canada, Japan, China, etc.)

Module #3
FDA Regulations (USA)
Overview of FDAs 510(k) and PMA processes, device classification, and compliance requirements

Module #4
EU Medical Device Regulation (MDR)
Overview of EU MDR, device classification, CE marking, and Notified Body roles

Module #5
ISO 13485:Quality Management Systems
Understanding ISO 13485 requirements for quality management systems in medical device manufacturing

Module #6
Risk Management and Hazard Analysis
Risk management principles, hazard analysis, and mitigation strategies for medical devices

Module #7
Clinical Evaluation and Investigation
Clinical evaluation and investigation requirements for medical devices, including clinical trials and post-market surveillance

Module #8
Design Controls and Design Verification
Design controls, design verification, and design validation for medical devices

Module #9
Manufacturing and Sterilization Controls
Manufacturing controls, sterilization methods, and control of contamination for medical devices

Module #10
Labeling and Packaging Requirements
Labeling and packaging requirements for medical devices, including UDI and e-labeling

Module #11
Post-Market Surveillance and Vigilance
Post-market surveillance, adverse event reporting, and vigilance requirements for medical devices

Module #12
Canadian Medical Device Regulations
Overview of Health Canadas medical device regulations, licensing, and compliance requirements

Module #13
Japanese Medical Device Regulations
Overview of Japanese medical device regulations, PMDA requirements, and compliance strategies

Module #14
Chinese Medical Device Regulations
Overview of Chinese medical device regulations, NMPA requirements, and compliance strategies

Module #15
Brazilian Medical Device Regulations
Overview of Brazilian medical device regulations, ANVISA requirements, and compliance strategies

Module #16
Regulatory Requirements for IVDs and Companion Diagnostics
Specific regulatory requirements for in vitro diagnostic devices and companion diagnostics

Module #17
Software as a Medical Device (SaMD) Regulations
Regulatory requirements for software as a medical device, including FDA and EU guidance

Module #18
Cybersecurity Requirements for Medical Devices
Overview of cybersecurity requirements for medical devices, including FDA and EU guidance

Module #19
Quality System Regulations and Audits
Quality system regulations, audit prepareness, and management of audit findings

Module #20
Regulatory Submissions and Dossier Preparation
Preparation of regulatory submissions, including dossier preparation and electronic submissions

Module #21
Regulatory Inspection and Enforcement
Inspection and enforcement strategies, managing regulatory inspections, and responding to regulatory actions

Module #22
Global Harmonization Efforts
Overview of global harmonization efforts, including IMDRF and GHTF initiatives

Module #23
Regulatory Intelligence and Compliance Strategies
Strategies for regulatory intelligence, compliance, and staying up-to-date with changing regulations

Module #24
Case Studies and Best Practices
Real-world case studies and best practices in medical device regulatory compliance

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Global Medical Device Regulatory Requirements career

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Global Medical Device Regulatory Requirements ( 25 Modules )

Global Medical Device Regulatory Requirements
( 25 Modules )