Regulatory Compliance and Quality Systems for Medical Devices
( 25 Modules )

Module #1
Introduction to Regulatory Compliance and Quality Systems
Overview of regulatory requirements and quality systems for medical devices

Module #2
Global Regulatory Framework
Understanding international regulatory requirements for medical devices

Module #3
FDA Overview and Medical Device Regulation
FDAs role in regulating medical devices in the United States

Module #4
EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
Understanding the EUs medical device and IVD regulations

Module #5
ISO 13485:2016 Medical Device Quality Management System Standard
Overview of the ISO 13485 standard and its application

Module #6
Quality System Essentials
Understanding the components of a quality system for medical devices

Module #7
Design Control and Product Development
Design control principles and best practices for medical device development

Module #8
Risk Management for Medical Devices
Understanding and implementing risk management principles for medical devices

Module #9
Production and Process Control
Best practices for production and process control in medical device manufacturing

Module #10
Corrective and Preventive Action (CAPA) and Nonconformity Management
Understanding and implementing CAPA and nonconformity management processes

Module #11
Change Control and Configuration Management
Best practices for change control and configuration management in medical device development

Module #12
Supplier Selection and Management
Understanding and implementing supplier selection and management processes

Module #13
Labeling and Packaging for Medical Devices
Regulatory requirements and best practices for labeling and packaging medical devices

Module #14
Sterilization and Packaging Validation
Understanding sterilization and packaging validation for medical devices

Module #15
Clinical Evaluation and Clinical trials
Understanding clinical evaluation and clinical trial requirements for medical devices

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

Module #17
Regulatory Submission and Approval Process
Understanding the regulatory submission and approval process for medical devices

Module #18
Quality Audits and Regulatory Inspections
Preparing for and understanding quality audits and regulatory inspections

Module #19
Compliance and Enforcement
Understanding compliance and enforcement regulations for medical devices

Module #20
Medical Device Classification and Regulatory Pathways
Understanding medical device classification and regulatory pathways

Module #21
Unique Device Identification (UDI) and Labeling
Understanding UDI and labeling requirements for medical devices

Module #22
Medical Device Software and Cybersecurity
Understanding medical device software and cybersecurity requirements

Module #23
Regulatory Requirements for Medical Device Accessories
Understanding regulatory requirements for medical device accessories

Module #24
Best Practices for Implementing a Quality System
Implementing and maintaining a quality system for medical devices

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Compliance and Quality Systems for Medical Devices career

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Regulatory Compliance and Quality Systems for Medical Devices ( 25 Modules )

Regulatory Compliance and Quality Systems for Medical Devices
( 25 Modules )