Regulatory Issues in Biomedical Device Development
( 25 Modules )

Module #1
Introduction to Regulatory Affairs
Overview of regulatory requirements for biomedical device development and importance of regulatory compliance

Module #2
Global Regulatory Landscape
Regulatory frameworks and agencies worldwide, including FDA, EU, and others

Module #3
Device Classification and Categorization
Understanding device classification and categorization, including risk-based classification and FDAs device classification system

Module #4
510(k) Premarket Notification
Overview of the 510(k) submission process, including device description, technical specifications, and performance data

Module #5
Premarket Approval (PMA) Process
In-depth review of the PMA process, including application requirements and clinical trial design

Module #6
Human Factors and Usability Engineering
Understanding human factors principles and usability engineering methods to ensure device safety and effectiveness

Module #7
Design Controls and Risk Management
Implementing design controls and risk management strategies to ensure device safety and regulatory compliance

Module #8
Quality System Regulations (QSR) and ISO 13485
Overview of QSR and ISO 13485 requirements for device manufacturers, including quality management systems and process controls

Module #9
Clinical Trials and Investigational Device Exemptions (IDEs)
Understanding clinical trial design, conduct, and reporting, including IDE requirements and institutional review boards

Module #10
Good Manufacturing Practices (GMPs) and Quality Control
Implementing GMPs and quality control measures to ensure device manufacturing and distribution compliance

Module #11
Labeling and Advertising Regulations
Understanding regulations governing device labeling, advertising, and promotion, including false or misleading claims

Module #12
Post-Market Surveillance and Vigilance
Implementing post-market surveillance and vigilance strategies to monitor device performance and address adverse events

Module #13
Corrective and Preventive Actions (CAPA) and Recall Procedures
Understanding CAPA and recall procedures, including root cause analysis and corrective action implementation

Module #14
Medical Device Reporting (MDR) and Adverse Event Reporting
Understanding MDR requirements and adverse event reporting, including reporting timelines and requirements

Module #15
European Union (EU) Medical Device Regulation (MDR)
Overview of EU MDR requirements, including device classification, technical documentation, and conformity assessment

Module #16
Asia-Pacific Regulatory Requirements
Understanding regulatory requirements in Asia-Pacific countries, including Japan, China, and Australia

Module #17
Regulatory Strategy and Planning
Developing a regulatory strategy and plan to ensure successful device development and commercialization

Module #18
Regulatory Submissions and Interactions
Understanding regulatory submission requirements and best practices for effective interactions with regulatory agencies

Module #19
Device Sterilization and Packaging Validation
Understanding sterilization and packaging validation requirements, including ISO standards and regulatory expectations

Module #20
Software and Cybersecurity Regulations
Understanding software and cybersecurity regulations, including FDA guidance and international standards

Module #21
Combination Products and Borderline Devices
Understanding combination products and borderline devices, including regulatory requirements and jurisdictional considerations

Module #22
Regulatory Inspections and Audits
Preparing for and responding to regulatory inspections and audits, including FDA and Notified Body inspections

Module #23
Regulatory Affairs and Quality Assurance
The role of regulatory affairs in ensuring quality assurance and compliance, including quality management systems and process controls

Module #24
Staying Current with Regulatory Changes
Staying informed about changing regulatory requirements and expectations, including FDA guidance and international standards

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Issues in Biomedical Device Development career

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Regulatory Issues in Biomedical Device Development ( 25 Modules )

Regulatory Issues in Biomedical Device Development
( 25 Modules )