Module #1 Introduction to Regulatory Compliance for Medical Devices Overview of the importance of regulatory compliance in the medical device industry, and the scope of the course.
Module #2 Global Regulatory Frameworks Comparison of regulatory frameworks for medical devices across regions, including EU, US, Canada, and Asia Pacific.
Module #3 FDA Regulations for Medical Devices In-depth review of FDA regulations for medical devices, including device classification, premarket submissions, and postmarket requirements.
Module #4 EU Medical Device Regulations (MDR) Overview of the EU Medical Device Regulations (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR), including device classification, technical files, and CE marking.
Module #5 ISO 13485:Medical Device Quality Management Systems Understanding of the requirements for a quality management system for medical devices, including risk management, design controls, and auditing.
Module #6 Device Classification and Coding Understanding of device classification systems, including FDA, EU, and GMDN codes, and their impact on regulatory strategies.
Module #7 Risk Management for Medical Devices Application of risk management principles to medical devices, including risk analysis, evaluation, and control.
Module #8 Design Controls and Design Verification Understanding of design controls, including design inputs, design outputs, and design verification, and their role in regulatory compliance.
Module #9 Premarket Submissions and Approvals Overview of premarket submissions, including 510(k), PMA, and De Novo pathways, and the regulatory approval process.
Module #10 Clinical Trials and Clinical Evaluations Understanding of clinical trials and clinical evaluations, including good clinical practice (GCP) and clinical trial design.
Module #11 Labeling and Packaging Regulatory requirements for labeling and packaging of medical devices, including IFU, labeling, and UDI requirements.
Module #12 Postmarket Surveillance and Vigilance Understanding of postmarket surveillance and vigilance, including adverse event reporting, corrective actions, and recall management.
Module #13 Compliance with Medical Device Directives Overview of compliance with medical device directives, including the Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD).
Module #14 S sterilization and Cleaning Validation Understanding of sterilization and cleaning validation, including radiation sterilization, ethylene oxide sterilization, and cleaning validation methods.
Module #15 Electrical Safety and Electromagnetic Compatibility Regulatory requirements for electrical safety and electromagnetic compatibility, including IEC 60601-1 and IEC 61000-4.
Module #16 Supply Chain Management and Vendor Management Best practices for supply chain management and vendor management, including supplier selection, auditing, and management.
Module #17 Regulatory Audit and Inspection Readiness Preparing for regulatory audits and inspections, including audit protocols and corrective action responses.
Module #18 Compliance with International Standards Overview of international standards for medical devices, including ISO 14971, IEC 62304, and IEC 62366.
Module #19 Medical Device Software and Cybersecurity Regulatory requirements for medical device software and cybersecurity, including FDA guidance and IEC 62304.
Module #20 Compliance with Combination Product Regulations Understanding of combination product regulations, including FDA guidance and EU Medical Device Regulations.
Module #21 Regulatory Compliance for Medical Device Accessories Regulatory requirements for medical device accessories, including FDA and EU regulations.
Module #22 Regulatory Compliance for In Vitro Diagnostic Devices Overview of regulatory requirements for in vitro diagnostic devices, including EU IVDR and FDA regulations.
Module #23 Regulatory Compliance for Custom-Made Devices Understanding of regulatory requirements for custom-made devices, including FDA and EU regulations.
Module #24 Regulatory Compliance for Investigational Devices Overview of regulatory requirements for investigational devices, including FDA IDE and EU regulations.
Module #25 Course Wrap-Up & Conclusion Planning next steps in Regulatory Compliance for Medical Devices career
