Mastering ISO 14155: A Step-by-Step Guide to Medical Device Clinical Investigations and Risk Management
Course Overview This comprehensive course provides a step-by-step guide to mastering ISO 14155, the international standard for medical device clinical investigations and risk management. Participants will gain a deep understanding of the standard's requirements and learn how to apply them in real-world scenarios.
Course Objectives - Understand the principles and requirements of ISO 14155
- Learn how to design and conduct clinical investigations that meet ISO 14155 standards
- Develop a risk management framework that complies with ISO 14155
- Apply ISO 14155 principles to real-world medical device development and clinical investigation scenarios
- Prepare for ISO 14155 certification and audits
Course Outline Module 1: Introduction to ISO 14155
- Overview of ISO 14155 and its importance in medical device development
- History and evolution of the standard
- Key principles and concepts
Module 2: Clinical Investigation Planning
- Defining clinical investigation objectives and scope
- Identifying and selecting investigation sites and investigators
- Developing a clinical investigation plan and protocol
- Establishing a clinical investigation timeline and budget
Module 3: Risk Management
- Introduction to risk management principles and concepts
- Identifying and assessing risks associated with medical devices
- Developing a risk management plan and implementing risk controls
- Monitoring and reviewing risk management activities
Module 4: Clinical Investigation Conduct
- Initiating and conducting clinical investigations
- Managing investigation sites and investigators
- Collecting and managing clinical data
- Ensuring compliance with ISO 14155 and regulatory requirements
Module 5: Clinical Investigation Reporting
- Developing a clinical investigation report
- Presenting and interpreting clinical data
- Addressing regulatory and ISO 14155 requirements for reporting
- Preparing for regulatory submissions and audits
Module 6: ISO 14155 Audits and Certification
- Preparing for ISO 14155 audits and certification
- Understanding audit requirements and processes
- Developing a corrective action plan and implementing changes
- Maintaining ISO 14155 certification and compliance
Module 7: Real-World Applications and Case Studies
- Applying ISO 14155 principles to real-world medical device development and clinical investigation scenarios
- Examining case studies and lessons learned
- Discussing best practices and common pitfalls
Course Features - Interactive and Engaging: The course includes interactive elements, such as quizzes, games, and discussions, to keep participants engaged and motivated.
- Comprehensive and Personalized: The course covers all aspects of ISO 14155 and provides personalized feedback and support to ensure participants achieve their learning objectives.
- Up-to-date and Practical: The course is regularly updated to reflect the latest developments and best practices in medical device clinical investigations and risk management.
- Real-world Applications: The course includes real-world examples and case studies to illustrate key concepts and principles.
- High-quality Content: The course is developed by expert instructors with extensive experience in medical device development and clinical investigations.
- Certification: Participants receive a certificate upon completion, issued by The Art of Service.
- Flexible Learning: The course is designed to accommodate different learning styles and schedules, with flexible access to course materials and support.
- User-friendly and Mobile-accessible: The course is delivered through a user-friendly and mobile-accessible platform, allowing participants to access course materials and support on-the-go.
- Community-driven: The course includes access to a community of peers and experts, providing opportunities for networking and collaboration.
- Actionable Insights: The course provides actionable insights and practical recommendations for improving medical device clinical investigations and risk management.
- Hands-on Projects: The course includes hands-on projects and exercises to help participants apply key concepts and principles in practice.
- Bite-sized Lessons: The course is structured into bite-sized lessons, allowing participants to learn at their own pace and convenience.
- Lifetime Access: Participants receive lifetime access to course materials and support, ensuring ongoing learning and professional development.
- Gamification and Progress Tracking: The course includes gamification elements and progress tracking, providing a fun and engaging learning experience.
,
- Understand the principles and requirements of ISO 14155
- Learn how to design and conduct clinical investigations that meet ISO 14155 standards
- Develop a risk management framework that complies with ISO 14155
- Apply ISO 14155 principles to real-world medical device development and clinical investigation scenarios
- Prepare for ISO 14155 certification and audits
Course Outline Module 1: Introduction to ISO 14155
- Overview of ISO 14155 and its importance in medical device development
- History and evolution of the standard
- Key principles and concepts
Module 2: Clinical Investigation Planning
- Defining clinical investigation objectives and scope
- Identifying and selecting investigation sites and investigators
- Developing a clinical investigation plan and protocol
- Establishing a clinical investigation timeline and budget
Module 3: Risk Management
- Introduction to risk management principles and concepts
- Identifying and assessing risks associated with medical devices
- Developing a risk management plan and implementing risk controls
- Monitoring and reviewing risk management activities
Module 4: Clinical Investigation Conduct
- Initiating and conducting clinical investigations
- Managing investigation sites and investigators
- Collecting and managing clinical data
- Ensuring compliance with ISO 14155 and regulatory requirements
Module 5: Clinical Investigation Reporting
- Developing a clinical investigation report
- Presenting and interpreting clinical data
- Addressing regulatory and ISO 14155 requirements for reporting
- Preparing for regulatory submissions and audits
Module 6: ISO 14155 Audits and Certification
- Preparing for ISO 14155 audits and certification
- Understanding audit requirements and processes
- Developing a corrective action plan and implementing changes
- Maintaining ISO 14155 certification and compliance
Module 7: Real-World Applications and Case Studies
- Applying ISO 14155 principles to real-world medical device development and clinical investigation scenarios
- Examining case studies and lessons learned
- Discussing best practices and common pitfalls
Course Features - Interactive and Engaging: The course includes interactive elements, such as quizzes, games, and discussions, to keep participants engaged and motivated.
- Comprehensive and Personalized: The course covers all aspects of ISO 14155 and provides personalized feedback and support to ensure participants achieve their learning objectives.
- Up-to-date and Practical: The course is regularly updated to reflect the latest developments and best practices in medical device clinical investigations and risk management.
- Real-world Applications: The course includes real-world examples and case studies to illustrate key concepts and principles.
- High-quality Content: The course is developed by expert instructors with extensive experience in medical device development and clinical investigations.
- Certification: Participants receive a certificate upon completion, issued by The Art of Service.
- Flexible Learning: The course is designed to accommodate different learning styles and schedules, with flexible access to course materials and support.
- User-friendly and Mobile-accessible: The course is delivered through a user-friendly and mobile-accessible platform, allowing participants to access course materials and support on-the-go.
- Community-driven: The course includes access to a community of peers and experts, providing opportunities for networking and collaboration.
- Actionable Insights: The course provides actionable insights and practical recommendations for improving medical device clinical investigations and risk management.
- Hands-on Projects: The course includes hands-on projects and exercises to help participants apply key concepts and principles in practice.
- Bite-sized Lessons: The course is structured into bite-sized lessons, allowing participants to learn at their own pace and convenience.
- Lifetime Access: Participants receive lifetime access to course materials and support, ensuring ongoing learning and professional development.
- Gamification and Progress Tracking: The course includes gamification elements and progress tracking, providing a fun and engaging learning experience.
,
- Interactive and Engaging: The course includes interactive elements, such as quizzes, games, and discussions, to keep participants engaged and motivated.
- Comprehensive and Personalized: The course covers all aspects of ISO 14155 and provides personalized feedback and support to ensure participants achieve their learning objectives.
- Up-to-date and Practical: The course is regularly updated to reflect the latest developments and best practices in medical device clinical investigations and risk management.
- Real-world Applications: The course includes real-world examples and case studies to illustrate key concepts and principles.
- High-quality Content: The course is developed by expert instructors with extensive experience in medical device development and clinical investigations.
- Certification: Participants receive a certificate upon completion, issued by The Art of Service.
- Flexible Learning: The course is designed to accommodate different learning styles and schedules, with flexible access to course materials and support.
- User-friendly and Mobile-accessible: The course is delivered through a user-friendly and mobile-accessible platform, allowing participants to access course materials and support on-the-go.
- Community-driven: The course includes access to a community of peers and experts, providing opportunities for networking and collaboration.
- Actionable Insights: The course provides actionable insights and practical recommendations for improving medical device clinical investigations and risk management.
- Hands-on Projects: The course includes hands-on projects and exercises to help participants apply key concepts and principles in practice.
- Bite-sized Lessons: The course is structured into bite-sized lessons, allowing participants to learn at their own pace and convenience.
- Lifetime Access: Participants receive lifetime access to course materials and support, ensuring ongoing learning and professional development.
- Gamification and Progress Tracking: The course includes gamification elements and progress tracking, providing a fun and engaging learning experience.