Regulatory Compliance for Medical Devices
( 25 Modules )

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

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Regulatory Compliance for Medical Devices ( 25 Modules )

Regulatory Compliance for Medical Devices
( 25 Modules )