Regulatory Affairs for Medical Devices
( 25 Modules )

Module #1
Introduction to Medical Device Regulation
Overview of the regulatory landscape for medical devices, importance of regulatory affairs, and key concepts

Module #2
Global Regulatory Framework
Comparison of regulatory frameworks in USA, EU, Canada, Australia, and Asia

Module #3
FDA Regulations for Medical Devices
Overview of FDAs Center for Devices and Radiological Health (CDRH), device classification, and regulatory pathways

Module #4
EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
Overview of EU MDR and IVDR, device classification, and conformity assessment

Module #5
Risk Management and ISO 14971
Principles of risk management, ISO 14971 standard, and risk analysis techniques

Module #6
Device Classification and Categorization
Classification of devices based on risk, FDA and EU classification systems, and device categorization

Module #7
Premarket Notification (510(k)) Submissions
Requirements and process for 510(k) submissions, including device description, technical documentation, and study protocols

Module #8
Premarket Approval (PMA) Applications
Requirements and process for PMA applications, including clinical trials, device description, and technical documentation

Module #9
Human Factors and Usability Engineering
Principles of human factors and usability engineering, user-centered design, and usability testing

Module #10
Clinical Trials for Medical Devices
Design and conduct of clinical trials, including study protocols, data analysis, and reporting

Module #11
Quality Management Systems (QMS) for Medical Devices
ISO 13485 standard, QMS principles, and requirements for medical device manufacturers

Module #12
Design Controls and Design Verification
Design control principles, design inputs, outputs, and verification, and design validation techniques

Module #13
Labeling and Instructions for Use
Labeling requirements, instructions for use, and other documentation for medical devices

Module #14
Sterilization and Packaging Validation
Sterilization methods, validation of sterilization processes, and packaging validation techniques

Module #15
Medical Device Safety and Recall Management
Safety reporting, recall management, and corrective actions for medical devices

Module #16
Postmarket Surveillance and Vigilance
Postmarket surveillance, vigilance reporting, and postmarket studies for medical devices

Module #17
Audits and Inspections for Medical Device Manufacturers
Types of audits and inspections, audit preparation, and response to audit findings

Module #18
Compliance and Enforcement for Medical Devices
Regulatory compliance, enforcement actions, and mitigation strategies for non-compliance

Module #19
Medical Device Software and Cybersecurity
Software development and validation, cybersecurity risks, and mitigation strategies for medical devices

Module #20
Medical Device Combination Products
Regulation of combination products, including drugs, biologics, and devices

Module #21
Regulatory Strategies for Medical Device Startups
Regulatory considerations for startups, including FDAs Expedited Access for Premarket Approval (EAP) program

Module #22
Regulatory Intelligence and Landscape Analysis
Regulatory intelligence gathering, industry trends, and competitive landscape analysis

Module #23
International Regulatory Submissions and Approvals
Regulatory submissions and approvals for markets outside the USA and EU, including Canada, Australia, and Asia

Module #24
Regulatory Affairs and Quality Management System Implementation
Implementation of regulatory affairs and quality management systems in medical device organizations

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Affairs for Medical Devices career

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Regulatory Affairs for Medical Devices ( 25 Modules )

Regulatory Affairs for Medical Devices
( 25 Modules )