Regulatory Pathways for Medical Device Approval
( 25 Modules )

Module #1
Introduction to Regulatory Affairs for Medical Devices
Overview of the importance of regulatory affairs in medical device development and approval

Module #2
Overview of Global Regulatory Frameworks
Comparison of regulatory frameworks and agencies worldwide, including FDA, EU, and Health Canada

Module #3
FDA Overview and History
History and organization of the FDA, including the role of CDRH and CBER

Module #4
FDA Medical Device Classification
Understanding the FDAs classification system for medical devices, including Class I, II, and III devices

Module #5
PMA vs. 510(k) Clearance
Comparison of the PMA and 510(k) clearance pathways, including criteria and requirements

Module #6
Premarket Approval (PMA) Process
Step-by-step guide to the PMA process, including submission and review

Module #7
510(k) Clearance Process
Step-by-step guide to the 510(k) clearance process, including submission and review

Module #8
Human Factors and Usability
Importance of human factors and usability in medical device design and approval

Module #9
Clinical Trials for Medical Devices
Designing and conducting clinical trials for medical devices, including IDE and IND applications

Module #10
Quality System Regulation (QSR) and ISO 13485
Overview of QSR and ISO 13485 requirements for medical device manufacturers

Module #11
Design Controls and Design Verification
Implementing design controls and design verification for medical devices

Module #12
Risk Management and Hazard Analysis
Conducting risk management and hazard analysis for medical devices

Module #13
Sterilization and Biocompatibility
Understanding sterilization and biocompatibility requirements for medical devices

Module #14
Labeling and Packaging
Regulatory requirements for labeling and packaging of medical devices

Module #15
EU Medical Device Regulation (MDR) Overview
Overview of the EUs Medical Device Regulation and its impact on medical device manufacturers

Module #16
CE Marking and Notified Bodies
Understanding CE mark requirements and the role of notified bodies in the EU

Module #17
Technical Files and Design Dossiers
Preparing technical files and design dossiers for EU regulatory approval

Module #18
Health Canada Overview and Medical Device Licensing
Overview of Health Canadas regulatory framework and medical device licensing requirements

Module #19
Australian Regulatory Framework and TGA Approval
Overview of the Australian regulatory framework and TGA approval process

Module #20
Regulatory Strategies for Combination Products
Strategies for regulatory approval of combination products

Module #21
FDA Inspections and Audits
Preparing for and managing FDA inspections and audits

Module #22
Post-Market Surveillance and Vigilance
Importance of post-market surveillance and vigilance for medical devices

Module #23
Recalls and Corrections
Managing recalls and corrections for medical devices

Module #24
Regulatory Intelligence and Compliance
Staying up-to-date with regulatory changes and ensuring compliance

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Pathways for Medical Device Approval career

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Regulatory Pathways for Medical Device Approval ( 25 Modules )

Regulatory Pathways for Medical Device Approval
( 25 Modules )