What does the ISO 14155 course cover?
ISO 14155 is covered here in 7 modules: Introduction to ISO 14155: Key principles and concepts, History and evolution of the standard, Clinical Investigation Planning: Defining clinical investigation objectives and scope, Risk Management: Monitoring and reviewing activities, Introduction to principles and concepts and 4 more.
How do you approach ISO 14155 step by step?
The work is sequenced in 7 stages. It starts with introduction to ISO 14155: Key principles and concepts, History and evolution of the standard, moves through Clinical Investigation Planning: Defining clinical investigation objectives and scope and Risk Management: Monitoring and reviewing activities, Introduction to principles and concepts, and ends at Real-World Applications and Case Studies: Examining case studies and lessons learned.
What is in Module 1 of the ISO 14155 course?
Module 1 is Introduction to ISO 14155: Key principles and concepts, History and evolution of the standard. It works through overview of ISO 14155 and its importance in medical device development, history and evolution of the standard and key principles and concepts. It sets the vocabulary the remaining 6 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 14155 Masterclass, Clinical Investigation and Medical Device Regulation, ISO 14155 Clinical Investigations of Medical Devices.
More answers: what you get with every course, refund policy, all help answers.
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: Key principles and concepts, History and evolution of the standard
- 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
- 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: Monitoring and reviewing activities, Introduction to principles and concepts
- 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: Collecting and managing clinical data
- 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: Presenting and interpreting clinical data
- 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: Understanding audit requirements and processes
- 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: Examining case studies and lessons learned
- 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.