ISO 14155: A Complete Guide to Clinical Investigation of Medical Devices for Human Subjects - Implementation Checklist and Compliance Essentials
Course Overview This comprehensive course is designed to provide a detailed understanding of the ISO 14155 standard for clinical investigation of medical devices for human subjects. Participants will gain a thorough knowledge of the requirements and guidelines for conducting clinical investigations, ensuring compliance with regulatory requirements and industry best practices.
Course Objectives - Understand the principles and requirements of ISO 14155 for clinical investigation of medical devices
- Develop a comprehensive implementation checklist for clinical investigations
- Ensure compliance with regulatory requirements and industry best practices
- Apply knowledge to real-world scenarios and case studies
- Receive a certificate upon completion issued by The Art of Service
Course Outline Module 1: Introduction to ISO 14155
- Overview of the ISO 14155 standard
- History and evolution of the standard
- Purpose and scope of the standard
- Key definitions and terminology
Module 2: Principles of Clinical Investigation
- Ethical principles for clinical investigations
- Risk assessment and management
- Clinical investigation planning and design
- Selection of clinical investigation sites and personnel
Module 3: Clinical Investigation Planning
- Development of a clinical investigation plan
- Identification of clinical investigation objectives and endpoints
- Selection of participants and inclusion/exclusion criteria
- Determination of sample size and statistical analysis
Module 4: Conducting Clinical Investigations
- Implementation of the clinical investigation plan
- Data collection and management
- Monitoring and auditing of clinical investigations
- Handling of adverse events and deviations
Module 5: Clinical Investigation Documentation
- Preparation of clinical investigation reports
- Documentation of clinical investigation data and results
- Maintenance of clinical investigation records
- Archiving and retention of clinical investigation documents
Module 6: Regulatory Compliance and Industry Best Practices
- Overview of regulatory requirements for clinical investigations
- Compliance with Good Clinical Practice (GCP) and ISO 14155
- Industry best practices for clinical investigations
- Auditing and inspection readiness
Module 7: Case Studies and Real-World Applications
- Case studies of successful clinical investigations
- Real-world applications of ISO 14155
- Lessons learned and best practices from industry experts
- Group discussions and interactive exercises
Module 8: Implementation Checklist and Compliance Essentials
- Development of a comprehensive implementation checklist
- Key compliance essentials for clinical investigations
- Tools and resources for ensuring compliance
- Practical tips for successful implementation
Course Features - Interactive and engaging: Interactive lessons, group discussions, and hands-on projects
- Comprehensive and up-to-date: Coverage of the latest regulatory requirements and industry best practices
- Personalized learning: Opportunities for feedback and questions
- Practical and real-world: Case studies and real-world applications
- Expert instructors: Experienced professionals with industry expertise
- Certification: Certificate upon completion issued by The Art of Service
- Flexible learning: Self-paced learning with lifetime access
- User-friendly and mobile-accessible: Course materials accessible on a variety of devices
- Community-driven: Opportunities for discussion and collaboration with peers
- Actionable insights: Practical takeaways and implementation guidance
- Hands-on projects: Opportunities to apply knowledge to real-world scenarios
- Bite-sized lessons: Manageable chunks of content for easier learning
- Gamification and progress tracking: Engaging features to track progress and stay motivated
What to Expect Upon Completion Upon completion of this course, participants will receive a certificate issued by The Art of Service, demonstrating their expertise in ISO 14155 and clinical investigation of medical devices. Participants will also have gained a comprehensive understanding of the requirements and guidelines for conducting clinical investigations, ensuring compliance with regulatory requirements and industry best practices.,
- Understand the principles and requirements of ISO 14155 for clinical investigation of medical devices
- Develop a comprehensive implementation checklist for clinical investigations
- Ensure compliance with regulatory requirements and industry best practices
- Apply knowledge to real-world scenarios and case studies
- Receive a certificate upon completion issued by The Art of Service
Course Outline Module 1: Introduction to ISO 14155
- Overview of the ISO 14155 standard
- History and evolution of the standard
- Purpose and scope of the standard
- Key definitions and terminology
Module 2: Principles of Clinical Investigation
- Ethical principles for clinical investigations
- Risk assessment and management
- Clinical investigation planning and design
- Selection of clinical investigation sites and personnel
Module 3: Clinical Investigation Planning
- Development of a clinical investigation plan
- Identification of clinical investigation objectives and endpoints
- Selection of participants and inclusion/exclusion criteria
- Determination of sample size and statistical analysis
Module 4: Conducting Clinical Investigations
- Implementation of the clinical investigation plan
- Data collection and management
- Monitoring and auditing of clinical investigations
- Handling of adverse events and deviations
Module 5: Clinical Investigation Documentation
- Preparation of clinical investigation reports
- Documentation of clinical investigation data and results
- Maintenance of clinical investigation records
- Archiving and retention of clinical investigation documents
Module 6: Regulatory Compliance and Industry Best Practices
- Overview of regulatory requirements for clinical investigations
- Compliance with Good Clinical Practice (GCP) and ISO 14155
- Industry best practices for clinical investigations
- Auditing and inspection readiness
Module 7: Case Studies and Real-World Applications
- Case studies of successful clinical investigations
- Real-world applications of ISO 14155
- Lessons learned and best practices from industry experts
- Group discussions and interactive exercises
Module 8: Implementation Checklist and Compliance Essentials
- Development of a comprehensive implementation checklist
- Key compliance essentials for clinical investigations
- Tools and resources for ensuring compliance
- Practical tips for successful implementation
Course Features - Interactive and engaging: Interactive lessons, group discussions, and hands-on projects
- Comprehensive and up-to-date: Coverage of the latest regulatory requirements and industry best practices
- Personalized learning: Opportunities for feedback and questions
- Practical and real-world: Case studies and real-world applications
- Expert instructors: Experienced professionals with industry expertise
- Certification: Certificate upon completion issued by The Art of Service
- Flexible learning: Self-paced learning with lifetime access
- User-friendly and mobile-accessible: Course materials accessible on a variety of devices
- Community-driven: Opportunities for discussion and collaboration with peers
- Actionable insights: Practical takeaways and implementation guidance
- Hands-on projects: Opportunities to apply knowledge to real-world scenarios
- Bite-sized lessons: Manageable chunks of content for easier learning
- Gamification and progress tracking: Engaging features to track progress and stay motivated
What to Expect Upon Completion Upon completion of this course, participants will receive a certificate issued by The Art of Service, demonstrating their expertise in ISO 14155 and clinical investigation of medical devices. Participants will also have gained a comprehensive understanding of the requirements and guidelines for conducting clinical investigations, ensuring compliance with regulatory requirements and industry best practices.,
- Interactive and engaging: Interactive lessons, group discussions, and hands-on projects
- Comprehensive and up-to-date: Coverage of the latest regulatory requirements and industry best practices
- Personalized learning: Opportunities for feedback and questions
- Practical and real-world: Case studies and real-world applications
- Expert instructors: Experienced professionals with industry expertise
- Certification: Certificate upon completion issued by The Art of Service
- Flexible learning: Self-paced learning with lifetime access
- User-friendly and mobile-accessible: Course materials accessible on a variety of devices
- Community-driven: Opportunities for discussion and collaboration with peers
- Actionable insights: Practical takeaways and implementation guidance
- Hands-on projects: Opportunities to apply knowledge to real-world scenarios
- Bite-sized lessons: Manageable chunks of content for easier learning
- Gamification and progress tracking: Engaging features to track progress and stay motivated