Medical Device Software Quality Management: A Step-by-Step Guide to Compliance and Regulatory Success
Course Overview This comprehensive course provides a step-by-step guide to medical device software quality management, covering the essential principles, requirements, and best practices for achieving compliance and regulatory success. Participants will gain a deep understanding of the regulatory framework, software development lifecycle, risk management, testing, and validation, as well as the skills to implement a quality management system that meets the requirements of ISO 13485, IEC 62304, and FDA regulations.
Course Objectives - Understand the regulatory requirements for medical device software quality management
- Implement a quality management system that meets the requirements of ISO 13485, IEC 62304, and FDA regulations
- Develop a software development lifecycle that ensures compliance and regulatory success
- Apply risk management principles to medical device software development
- Conduct testing and validation of medical device software
- Ensure compliance with post-market surveillance and vigilance requirements
Course Outline Module 1: Introduction to Medical Device Software Quality Management
- Overview of medical device software quality management
- Regulatory framework: ISO 13485, IEC 62304, and FDA regulations
- Quality management system requirements
- Software development lifecycle
Module 2: Regulatory Requirements for Medical Device Software
- IEC 62304: Medical device software - Software life cycle processes
- ISO 13485: Medical devices - Quality management systems
- FDA regulations: 21 CFR Part 820 and 21 CFR Part 11
- EU MDR and IVDR regulations
Module 3: Software Development Lifecycle
- Software development process
- Software requirements specification
- Software design and implementation
- Software testing and validation
- Software release and maintenance
Module 4: Risk Management for Medical Device Software
- Risk management principles
- Risk analysis and evaluation
- Risk control and mitigation
- Risk monitoring and review
Module 5: Testing and Validation of Medical Device Software
- Software testing principles
- Unit testing, integration testing, and system testing
- Validation and verification
- Test planning and execution
- Test reporting and documentation
Module 6: Post-Market Surveillance and Vigilance
- Post-market surveillance requirements
- Vigilance reporting and adverse event reporting
- Complaint handling and corrective action
- Product recall and withdrawal
Module 7: Quality Management System Implementation
- Quality policy and objectives
- Quality manual and procedures
- Document control and records management
- Training and awareness
- Internal audits and management review
Module 8: Auditing and Compliance
- Auditing principles and techniques
- Compliance with regulatory requirements
- Audit planning and execution
- Audit reporting and follow-up
Module 9: Case Studies and Group Discussions
- Real-world examples of medical device software quality management
- Group discussions and problem-solving exercises
- Sharing of best practices and experiences
Module 10: Final Project and Assessment
- Final project: Implementing a quality management system for medical device software
- Assessment and feedback
- Certificate of Completion
Course Features - Interactive and engaging: The course includes interactive modules, group discussions, and case studies to keep participants engaged and motivated.
- Comprehensive and up-to-date: The course covers the latest regulatory requirements and best practices in medical device software quality management.
- Personalized learning: Participants can learn at their own pace and access the course materials at any time.
- Expert instructors: The course is taught by experienced instructors with expertise in medical device software quality management.
- Certification: Participants receive a Certificate of Completion upon finishing the course.
- Flexible learning: The course is available online and can be accessed from any device.
- User-friendly: The course platform is easy to use and navigate.
- Mobile-accessible: The course can be accessed from any mobile device.
- Community-driven: Participants can connect with each other and share best practices and experiences.
- Actionable insights: The course provides actionable insights and practical advice that can be applied in real-world situations.
- Hands-on projects: The course includes hands-on projects and exercises to help participants apply the concepts learned.
- Bite-sized lessons: The course is divided into bite-sized lessons that can be completed in a short amount of time.
- Lifetime access: Participants have lifetime access to the course materials.
- Gamification: The course includes gamification elements to make learning fun and engaging.
- Progress tracking: Participants can track their progress and receive feedback on their performance.
Certificate of Completion Upon completing the course, participants will receive a Certificate of Completion issued by The Art of Service. This certificate is a recognition of the participant's achievement and demonstrates their commitment to medical device software quality management.,
- Understand the regulatory requirements for medical device software quality management
- Implement a quality management system that meets the requirements of ISO 13485, IEC 62304, and FDA regulations
- Develop a software development lifecycle that ensures compliance and regulatory success
- Apply risk management principles to medical device software development
- Conduct testing and validation of medical device software
- Ensure compliance with post-market surveillance and vigilance requirements
Course Outline Module 1: Introduction to Medical Device Software Quality Management
- Overview of medical device software quality management
- Regulatory framework: ISO 13485, IEC 62304, and FDA regulations
- Quality management system requirements
- Software development lifecycle
Module 2: Regulatory Requirements for Medical Device Software
- IEC 62304: Medical device software - Software life cycle processes
- ISO 13485: Medical devices - Quality management systems
- FDA regulations: 21 CFR Part 820 and 21 CFR Part 11
- EU MDR and IVDR regulations
Module 3: Software Development Lifecycle
- Software development process
- Software requirements specification
- Software design and implementation
- Software testing and validation
- Software release and maintenance
Module 4: Risk Management for Medical Device Software
- Risk management principles
- Risk analysis and evaluation
- Risk control and mitigation
- Risk monitoring and review
Module 5: Testing and Validation of Medical Device Software
- Software testing principles
- Unit testing, integration testing, and system testing
- Validation and verification
- Test planning and execution
- Test reporting and documentation
Module 6: Post-Market Surveillance and Vigilance
- Post-market surveillance requirements
- Vigilance reporting and adverse event reporting
- Complaint handling and corrective action
- Product recall and withdrawal
Module 7: Quality Management System Implementation
- Quality policy and objectives
- Quality manual and procedures
- Document control and records management
- Training and awareness
- Internal audits and management review
Module 8: Auditing and Compliance
- Auditing principles and techniques
- Compliance with regulatory requirements
- Audit planning and execution
- Audit reporting and follow-up
Module 9: Case Studies and Group Discussions
- Real-world examples of medical device software quality management
- Group discussions and problem-solving exercises
- Sharing of best practices and experiences
Module 10: Final Project and Assessment
- Final project: Implementing a quality management system for medical device software
- Assessment and feedback
- Certificate of Completion
Course Features - Interactive and engaging: The course includes interactive modules, group discussions, and case studies to keep participants engaged and motivated.
- Comprehensive and up-to-date: The course covers the latest regulatory requirements and best practices in medical device software quality management.
- Personalized learning: Participants can learn at their own pace and access the course materials at any time.
- Expert instructors: The course is taught by experienced instructors with expertise in medical device software quality management.
- Certification: Participants receive a Certificate of Completion upon finishing the course.
- Flexible learning: The course is available online and can be accessed from any device.
- User-friendly: The course platform is easy to use and navigate.
- Mobile-accessible: The course can be accessed from any mobile device.
- Community-driven: Participants can connect with each other and share best practices and experiences.
- Actionable insights: The course provides actionable insights and practical advice that can be applied in real-world situations.
- Hands-on projects: The course includes hands-on projects and exercises to help participants apply the concepts learned.
- Bite-sized lessons: The course is divided into bite-sized lessons that can be completed in a short amount of time.
- Lifetime access: Participants have lifetime access to the course materials.
- Gamification: The course includes gamification elements to make learning fun and engaging.
- Progress tracking: Participants can track their progress and receive feedback on their performance.
Certificate of Completion Upon completing the course, participants will receive a Certificate of Completion issued by The Art of Service. This certificate is a recognition of the participant's achievement and demonstrates their commitment to medical device software quality management.,
- Interactive and engaging: The course includes interactive modules, group discussions, and case studies to keep participants engaged and motivated.
- Comprehensive and up-to-date: The course covers the latest regulatory requirements and best practices in medical device software quality management.
- Personalized learning: Participants can learn at their own pace and access the course materials at any time.
- Expert instructors: The course is taught by experienced instructors with expertise in medical device software quality management.
- Certification: Participants receive a Certificate of Completion upon finishing the course.
- Flexible learning: The course is available online and can be accessed from any device.
- User-friendly: The course platform is easy to use and navigate.
- Mobile-accessible: The course can be accessed from any mobile device.
- Community-driven: Participants can connect with each other and share best practices and experiences.
- Actionable insights: The course provides actionable insights and practical advice that can be applied in real-world situations.
- Hands-on projects: The course includes hands-on projects and exercises to help participants apply the concepts learned.
- Bite-sized lessons: The course is divided into bite-sized lessons that can be completed in a short amount of time.
- Lifetime access: Participants have lifetime access to the course materials.
- Gamification: The course includes gamification elements to make learning fun and engaging.
- Progress tracking: Participants can track their progress and receive feedback on their performance.