What does the ISO 14155 course cover?
ISO 14155 is covered here in 8 modules: Introduction to ISO 14155: Key definitions and terminology, Purpose and scope of the standard, Principles of Clinical Investigation: Risk assessment and management, Clinical Investigation Planning: Development of a clinical investigation plan and 5 more.
How do you approach ISO 14155 step by step?
The work is sequenced in 8 stages. It starts with introduction to ISO 14155: Key definitions and terminology, Purpose and scope of the standard, moves through Principles of Clinical Investigation: Risk assessment and management and Clinical Investigation Planning: Development of a clinical investigation plan, and ends at Implementation Checklist and Compliance Essentials.
What is in Module 1 of the ISO 14155 course?
Module 1 is Introduction to ISO 14155: Key definitions and terminology, Purpose and scope of the standard. It works through overview of the ISO 14155 standard, history and evolution of the standard, purpose and scope of the standard and 1 more. It sets the vocabulary the remaining 7 modules build on.
How is the ISO 14155 course delivered?
The ISO 14155 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.
How much does the ISO 14155 course cost?
The ISO 14155 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.
Closely related courses: ISO 17020 Audit Checklist and Compliance Essentials, ISO 27003 Implementation Checklist and Planning Essentials, ISO 13485 Implementation Checklist and Compliance, ISO 27001 Implementation Checklist and Toolkit Essentials.
More answers: what you get with every course, refund policy, all help answers.
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: Key definitions and terminology, Purpose and scope of the standard
- 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: Risk assessment and management
- 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
- 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: Data collection and management
- 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
- 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: Auditing and inspection readiness
- 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: Real-world applications of ISO 14155
- 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