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
