Regulatory Requirements in Medical Device Design
( 25 Modules )

Module #1
Introduction to Medical Device Regulations
Overview of the importance of regulatory compliance in medical device design

Module #2
Global Regulatory Landscape
Introduction to major regulatory agencies and their roles

Module #3
.Device Classification and Regulatory Pathways
Understanding device classification and regulatory pathways

Module #4
Risk Management and Compliance
Overview of risk management principles and compliance strategies

Module #5
Regulatory Requirements for Device Development
Understanding regulatory requirements for device development, testing, and validation

Module #6
FDA Overview and Device Classification
In-depth look at FDA regulations and device classification

Module #7
510(k) Premarket Notification
Understanding the 510(k) process and requirements

Module #8
PMA (Premarket Approval) Process
In-depth look at the PMA process and requirements

Module #9
FDA Inspections and Audits
Preparing for and responding to FDA inspections and audits

Module #10
FDA Post-Market Surveillance and Reporting
Understanding post-market surveillance and reporting requirements

Module #11
EU MDR and IVDR Overview
Introduction to the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

Module #12
CE Marking and Conformity Assessment
Understanding the CE marking process and conformity assessment

Module #13
EU Technical Documentation and Labeling
Requirements for technical documentation and labeling

Module #14
International Regulations:Canada, Australia, and Japan
Overview of regulatory requirements in other major markets

Module #15
Harmonization and Global Regulatory Strategies
Strategies for harmonizing regulatory compliance across regions

Module #16
Design Controls and Verification
Understanding design controls and verification requirements

Module #17
Device Validation and Testing
Understanding device validation and testing requirements

Module #18
Quality Systems and ISO 13485
Overview of quality systems and ISO 13485 requirements

Module #19
Design History File (DHF) and Technical Files
Understanding DHF and technical file requirements

Module #20
CAPA and Complaint Handling
Understanding corrective action and preventive action (CAPA) and complaint handling requirements

Module #21
Software Validation and Cybersecurity
Understanding software validation and cybersecurity requirements

Module #22
Sterilization and Packaging Validation
Understanding sterilization and packaging validation requirements

Module #23
Labeling and Instructions for Use
Understanding labeling and instructions for use requirements

Module #24
Post-Market Clinical Follow-up and Vigilance
Understanding post-market clinical follow-up and vigilance requirements

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Requirements in Medical Device Design career

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Regulatory Requirements in Medical Device Design ( 25 Modules )

Regulatory Requirements in Medical Device Design
( 25 Modules )