Regulatory Aspects of Medical Device Innovation
( 25 Modules )

Module #1
Introduction to Medical Device Regulation
Overview of the importance of regulatory considerations in medical device innovation

Module #2
Global Regulatory Landscape
Survey of major regulatory frameworks for medical devices worldwide

Module #3
FDA Overview
Introduction to the US Food and Drug Administrations role in medical device regulation

Module #4
FDA Classification and Jurisdiction
Understanding FDA classification of medical devices and jurisdictional boundaries

Module #5
Device Classification:I, II, III
In-depth look at FDA classification of medical devices by risk level

Module #6
Pre-Submission Meetings and Interactions
Effective communication with FDA during the pre-submission phase

Module #7
510(k) Premarket Notification
Understanding the 510(k) submission process for medium-risk devices

Module #8
PMA:Premarket Approval
In-depth look at the PMA process for high-risk devices

Module #9
De Novo Classification
Navigating the De Novo pathway for novel devices

Module #10
Human Factors and Usability
Designing devices with user needs in mind:human factors and usability considerations

Module #11
Clinical Trials and Investigational Device Exemption (IDE)
Conducting clinical trials and obtaining IDE approval

Module #12
Design Controls and Design Verification
Implementing design controls and verification processes for medical devices

Module #13
Production and Process Controls
Establishing production and process controls for medical device manufacturing

Module #14
Labeling and Advertising
Compliance with labeling and advertising regulations for medical devices

Module #15
Post-Market Surveillance and Complaint Handling
Monitoring device performance and handling customer complaints post-launch

Module #16
Corrective and Preventive Actions (CAPA)
Implementing corrective and preventive actions to address device issues

Module #17
Regulatory Affairs:Strategy and Planning
Developing a regulatory strategy and planning for device development and approval

Module #18
CE Marking and EU Medical Device Regulation
Overview of the EU Medical Device Regulation and CE marking process

Module #19
Canada and Health Canada Regulations
Understanding medical device regulation in Canada and working with Health Canada

Module #20
Asian Markets:Japan, China, and Korea
Regulatory requirements and strategies for medical device approval in key Asian markets

Module #21
Software as a Medical Device (SaMD)
Unique regulatory considerations for software-based medical devices

Module #22
Combination Products and Cross-Labeling
Regulatory implications of combination products and cross-labeling

Module #23
Radiation-Emitting Devices and FDAs CDRH
Special considerations for radiation-emitting devices and working with FDAs CDRH

Module #24
Emerging Trends and Technologies
Exploring the impact of emerging trends and technologies on medical device regulation

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Aspects of Medical Device Innovation career

WIZAPE

ONLINE RESOURCES

ABOUT WIZAPE

ONLINE PORTAL

Our priority is to cultivate a vibrant community before considering the release of a token. By focusing on engagement and support, we can create a solid foundation for sustainable growth. Let’s build this together!

We're giving our website a fresh new look and feel! 🎉 Stay tuned as we work behind the scenes to enhance your experience.
Get ready for a revamped site that’s sleeker, and packed with new features. Thank you for your patience. Great things are coming!

CONTACT-US PRIVACY POLICY

Regulatory Aspects of Medical Device Innovation ( 25 Modules )

Regulatory Aspects of Medical Device Innovation
( 25 Modules )