What does the ISO 14155 course cover?
ISO 14155 is covered here in 8 modules: Introduction to Clinical Investigation: Overview of clinical investigation, Planning Clinical Investigations: Selecting the study design, Determining the sample size, Conducting Clinical Investigations: Obtaining informed consent and 5 more. The outline lists 33 specific topics, opening with overview of clinical investigation and closing with receiving a certificate upon completion.
How do you approach ISO 14155 step by step?
The work is sequenced in 8 stages. It starts with Introduction to Clinical Investigation: Overview of clinical investigation, moves through Planning Clinical Investigations: Selecting the study design, Determining the sample size and Conducting Clinical Investigations: Obtaining informed consent, and ends at Final Project and Assessment: Assessment and feedback, Completing a final project.
What is in Module 1 of the ISO 14155 course?
Module 1 is Introduction to Clinical Investigation: Overview of clinical investigation. It works through overview of clinical investigation, importance of clinical investigation in medical device development, regulatory requirements for clinical investigation 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 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.
ISO 14155: Mastering Clinical Investigation of Medical Devices - A Step-by-Step Guide to Ensuring Compliance and Success
Course Overview
This comprehensive course provides a step-by-step guide to mastering clinical investigation of medical devices, ensuring compliance with ISO 14155 and achieving success in the field. Participants will receive a certificate upon completion, issued by The Art of Service.Course Features
- Interactive: Engage with expert instructors and peers through interactive discussions and activities.
- Engaging: Enjoy a user-friendly and mobile-accessible learning platform.
- Comprehensive: Cover all aspects of clinical investigation, from planning to reporting.
- Personalized: Receive personalized feedback and support from expert instructors.
- Up-to-date: Stay current with the latest developments and updates in the field.
- Practical: Apply knowledge and skills through hands-on projects and real-world applications.
- High-quality content: Access high-quality, expert-developed content.
- Certification: Receive a certificate upon completion, issued by The Art of Service.
- Flexible learning: Learn at your own pace, with lifetime access to course materials.
- Gamification: Engage with gamification features, such as progress tracking and badges.
- Community-driven: Connect with a community of peers and expert instructors.
- Actionable insights: Gain actionable insights and practical skills to apply in your work.
- Hands-on projects: Complete hands-on projects to apply knowledge and skills.
- Bite-sized lessons: Learn through bite-sized lessons, easily digestible and manageable.
- Lifetime access: Enjoy lifetime access to course materials and updates.
- Progress tracking: Track your progress and stay motivated with gamification features.
Course Outline
Module 1. Introduction to Clinical Investigation: Overview of clinical investigation
- Overview of clinical investigation
- Importance of clinical investigation in medical device development
- Regulatory requirements for clinical investigation
- ISO 14155:2019 - Clinical investigation of medical devices for human subjects - Good clinical practice
Module 2. Planning Clinical Investigations: Selecting the study design, Determining the sample size
- Defining the clinical investigation question
- Developing the clinical investigation plan
- Identifying the target population
- Determining the sample size
- Selecting the study design
Module 3. Conducting Clinical Investigations: Obtaining informed consent
- Obtaining informed consent
- Conducting the clinical investigation
- Managing and reporting adverse events
- Maintaining study documentation
- Ensuring compliance with regulatory requirements
Module 4. Data Management and Analysis: Ensuring data quality, Conducting data analysis
- Collecting and managing data
- Ensuring data quality
- Conducting data analysis
- Interpreting results
- Reporting study findings
Module 5. Reporting Clinical Investigations: Publishing study findings
- Developing the clinical investigation report
- Ensuring compliance with reporting requirements
- Submitting the report to regulatory authorities
- Publishing study findings
Module 6. Regulatory Compliance and Ethics: Addressing conflicts of interest
- Overview of regulatory requirements for clinical investigation
- Ensuring compliance with ISO 14155
- Maintaining ethical standards in clinical investigation
- Addressing conflicts of interest
Module 7. Case Studies and Group Discussions: Group discussions and debates
- Real-world examples of clinical investigation
- Group discussions and debates
- Applying knowledge and skills to real-world scenarios
Module 8. Final Project and Assessment: Assessment and feedback, Completing a final project
- Completing a final project
- Assessment and feedback
- Receiving a certificate upon completion