Regulatory Compliance for Biomedical Equipment
( 25 Modules )

Module #1
Introduction to Regulatory Compliance
Overview of regulatory requirements for biomedical equipment and importance of compliance

Module #2
FDA Overview and Authority
History and role of the FDA, device classification, and regulatory pathways

Module #3
Device Classification and Regulations
Device classification, 510(k) clearance, PMA approval, and De Novo classification request

Module #4
Device Labeling and Advertising
Labeling requirements, advertising restrictions, and promotional materials

Module #5
Quality System Regulations (QSR)
Overview of QSR, design controls, and manufacturing requirements

Module #6
Design Controls and Design Verification
Design control principles, design input, and design verification

Module #7
Design Validation and Design Transfer
Design validation, design transfer, and production process validation

Module #8
Risk Management and Hazard Analysis
Risk management principles, hazard analysis, and risk assessment

Module #9
Corrective Action and Preventive Action (CAPA)
CAPA principles, corrective action, and preventive action

Module #10
Complaint Handling and Medical Device Reporting
Complaint handling process, MDR reporting, and recall regulations

Module #11
Audits and Inspections
Types of audits, inspection preparation, and responding to FDA 483 observations

Module #12
EU Medical Device Regulation (MDR) Overview
Overview of EU MDR, device classification, and CE marking

Module #13
EU Technical File and Design Dossier
Technical file and design dossier requirements, and Notified Body role

Module #14
ISO 13485:2016 Overview
Overview of ISO 13485:2016, quality management system, and audit principles

Module #15
Canadian Medical Device Regulations
Overview of Canadian regulations, device licensing, and Establishment Licenses

Module #16
Other International Regulations
Overview of regulations in Japan, China, and Australia, and global harmonization

Module #17
Regulatory Submissions and Approvals
Regulatory submission strategies, 510(k) submission, and PMA approval process

Module #18
Clinical Trials and Human Factors
Clinical trial requirements, human factors engineering, and usability testing

Module #19
Sterilization and Packaging Validation
Sterilization methods, packaging validation, and shelf-life determination

Module #20
Electrical Safety and Electromagnetic Compatibility
Electrical safety requirements, EMC testing, and IEC 60601-1 standards

Module #21
Environmental and Sustainability Considerations
Environmental regulations, sustainability principles, and eco-design

Module #22
Supply Chain and Vendor Management
Supply chain management, vendor selection, and contract manufacturer oversight

Module #23
Regulatory Compliance for Software as a Medical Device (SaMD)
Software regulations, SaMD classification, and cybersecurity requirements

Module #24
Cybersecurity and Data Privacy
Cybersecurity risks, data privacy regulations, and security testing

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Compliance for Biomedical Equipment career

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Regulatory Compliance for Biomedical Equipment ( 25 Modules )

Regulatory Compliance for Biomedical Equipment
( 25 Modules )