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
• 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

• 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
• Conducting the clinical investigation
• Managing and reporting adverse events
• Maintaining study documentation
• Ensuring compliance with regulatory requirements

Module 4: Data Management and Analysis

• Collecting and managing data
• Ensuring data quality
• Conducting data analysis
• Interpreting results
• Reporting study findings

Module 5: Reporting Clinical Investigations

• 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

• 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

• Real-world examples of clinical investigation
• Group discussions and debates
• Applying knowledge and skills to real-world scenarios

Module 8: Final Project and Assessment

• Completing a final project
• Assessment and feedback
• Receiving a certificate upon completion

Certificate of Completion

Participants who complete the course will receive a Certificate of Completion, issued by The Art of Service. This certificate demonstrates mastery of clinical investigation of medical devices and compliance with ISO 14155.

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