Regulatory Affairs for Biomedical Devices
( 25 Modules )

Module #1
Introduction to Regulatory Affairs
Overview of regulatory affairs in the biomedical device industry, importance, and relevance.

Module #2
Global Regulatory Framework
Comparison of regulatory frameworks in major regions (US, EU, Canada, Australia, Japan)

Module #3
FDA Regulations and Guidance
In-depth discussion of FDA regulations, guidance documents, and compliance requirements

Module #4
EU MDR and IVDR
Understanding the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

Module #5
Medical Device Classification
Classifying medical devices according to risk, intended use, and regulatory requirements

Module #6
Device Labeling and Marking
Global requirements for labeling and marking medical devices

Module #7
Clinical Trials and Investigational Device Exemptions (IDEs)
Conducting clinical trials and IDEs for medical devices in the US and EU

Module #8
510(k) Premarket Notifications
Preparation and submission of 510(k) premarket notifications to the FDA

Module #9
Premarket Approval (PMA) Applications
Preparation and submission of PMA applications to the FDA

Module #10
De Novo Classification Requests
Understanding and preparing De Novo classification requests for novel medical devices

Module #11
Human Factors and Usability Engineering
Importance of human factors and usability engineering in medical device design and development

Module #12
Risk Management and Hazard Analysis
Applying risk management and hazard analysis principles in medical device development

Module #13
Design Controls and Design Verification
Implementing design controls and design verification for medical devices

Module #14
Manufacturing and Quality Control
Regulatory requirements for manufacturing and quality control of medical devices

Module #15
Sterilization and Packaging
Regulatory requirements for sterilization and packaging of medical devices

Module #16
Post-Market Surveillance and Vigilance
Regulatory requirements for post-market surveillance and vigilance for medical devices

Module #17
Adverse Event Reporting and MDRs
Reporting adverse events and submitting MDRs to regulatory authorities

Module #18
Medical Device Recalls and Corrections
Regulatory requirements for medical device recalls and corrections

Module #19
Regulatory Audits and Inspections
Preparing for and responding to regulatory audits and inspections

Module #20
Quality Management Systems (QMS) and ISO 13485
Implementing and maintaining a QMS according to ISO 13485

Module #21
Regulatory Intelligence and Compliance
Staying informed about regulatory changes and updates

Module #22
Compliance with Combination Product Regulations
Regulatory requirements for combination products (drug-device, biologic-device)

Module #23
Software as a Medical Device (SaMD) and Cybersecurity
Regulatory requirements for SaMD and cybersecurity

Module #24
Regulatory Strategies for In Vitro Diagnostic Devices
Specific regulatory requirements for IVDs

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Affairs for Biomedical Devices 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 Affairs for Biomedical Devices ( 25 Modules )

Regulatory Affairs for Biomedical Devices
( 25 Modules )