Regulatory Issues for Wearable Medical Devices
( 25 Modules )

Module #1
Introduction to Wearable Medical Devices
Overview of wearable medical devices, their applications, and the importance of regulatory compliance

Module #2
Global Regulatory Landscape
Survey of regulatory frameworks for wearable medical devices worldwide, including FDA, CE, and ISO

Module #3
FDA Regulation of Wearable Medical Devices
In-depth review of FDA regulations, including 510(k), PMA, and De Novo pathways

Module #4
Medical Device Classification under FDA
Understanding FDA device classification, including Class I, II, and III devices

Module #5
EU CE Marking for Wearable Medical Devices
Overview of the EUs Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

Module #6
ISO 13485:Quality Management System for Medical Devices
Implementing a Quality Management System (QMS) according to ISO 13485

Module #7
Design Controls for Wearable Medical Devices
Understanding design controls, including design inputs, outputs, and verification

Module #8
Risk Management for Wearable Medical Devices
Identifying and mitigating risks associated with wearable medical devices

Module #9
Clinical Evaluation of Wearable Medical Devices
Conducting clinical evaluations, including literature reviews and clinical trials

Module #10
Technical File and Design Dossier Preparation
Preparing technical files and design dossiers for regulatory submissions

Module #11
Labeling and Packaging for Wearable Medical Devices
Complying with labeling and packaging requirements for wearable medical devices

Module #12
Sterilization and Validation for Wearable Medical Devices
Understanding sterilization and validation methods for wearable medical devices

Module #13
Post-Market Surveillance and Vigilance
Implementing post-market surveillance and vigilance strategies for wearable medical devices

Module #14
Adverse Event Reporting and Recall Procedures
Understanding adverse event reporting and recall procedures for wearable medical devices

Module #15
Electromagnetic Compatibility (EMC) and Safety
Ensuring electromagnetic compatibility and safety for wearable medical devices

Module #16
Cybersecurity for Wearable Medical Devices
Mitigating cybersecurity risks associated with wearable medical devices

Module #17
Data Privacy and Protection for Wearable Medical Devices
Complying with data privacy and protection regulations for wearable medical devices

Module #18
Software as a Medical Device (SaMD)
Understanding software as a medical device, including development and validation

Module #19
Artificial Intelligence and Machine Learning in Wearable Medical Devices
Regulatory considerations for AI and ML in wearable medical devices

Module #20
Wearable Medical Device Software Updates and Maintenance
Managing software updates and maintenance for wearable medical devices

Module #21
Regulatory Strategies for Wearable Medical Devices
Developing regulatory strategies for wearable medical devices, including pre-submission and post-approval

Module #22
Working with Notified Bodies and Regulatory Consultants
Tips for working with notified bodies and regulatory consultants for wearable medical devices

Module #23
Regulatory Challenges and Opportunities for Wearable Medical Devices
Exploring current challenges and opportunities in wearable medical device regulation

Module #24
Case Studies in Wearable Medical Device Regulation
Real-world examples and lessons learned from wearable medical device regulatory experiences

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

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Regulatory Issues for Wearable Medical Devices ( 25 Modules )

Regulatory Issues for Wearable Medical Devices
( 25 Modules )