Skip to main content
Mastering ISO 14155; Implementing and Auditing Medical Device Clinical Trials

Mastering ISO 14155; Implementing and Auditing Medical Device Clinical Trials

$199.00
When you get access:
Course access is prepared after purchase and delivered via email
How you learn:
Self-paced • Lifetime updates
Your guarantee:
30-day money-back guarantee — no questions asked
Who trusts this:
Trusted by professionals in 160+ countries
Adding to cart… The item has been added

Mastering ISO 14155: Implementing and Auditing Medical Device Clinical Trials

Mastering ISO 14155: Implementing and Auditing Medical Device Clinical Trials

This comprehensive course is designed to provide participants with a thorough understanding of the principles and requirements of ISO 14155, the international standard for clinical trials of medical devices. Upon completion of this course, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and Engaging: This course includes interactive lessons, quizzes, and hands-on projects to keep participants engaged and motivated.
  • Comprehensive: The course covers all aspects of ISO 14155, including the principles, requirements, and implementation of the standard.
  • Personalized: Participants can learn at their own pace and access the course materials at any time.
  • Up-to-date: The course is regularly updated to reflect the latest developments and changes in the standard.
  • Practical: The course includes real-world examples and case studies to illustrate the application of the standard.
  • High-quality Content: The course materials are developed by experts in the field and are designed to provide participants with a thorough understanding of the standard.
  • Expert Instructors: The course is taught by experienced instructors who are knowledgeable in the field of clinical trials and medical devices.
  • Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
  • Flexible Learning: The course is available online and can be accessed from any device, at any time.
  • User-friendly: The course platform is easy to use and navigate, making it accessible to participants of all skill levels.
  • Mobile-accessible: The course can be accessed from any mobile device, making it easy to learn on-the-go.
  • Community-driven: Participants can connect with other learners and instructors through the course forum, making it easy to ask questions and share knowledge.
  • Actionable Insights: The course provides participants with actionable insights and practical tips that can be applied in real-world settings.
  • Hands-on Projects: The course includes hands-on projects and exercises that allow participants to apply their knowledge and skills.
  • Bite-sized Lessons: The course is divided into bite-sized lessons, making it easy to learn and retain information.
  • Lifetime Access: Participants have lifetime access to the course materials, making it easy to review and refresh their knowledge at any time.
  • Gamification: The course includes gamification elements, such as quizzes and challenges, to make learning fun and engaging.
  • Progress Tracking: Participants can track their progress through the course, making it easy to stay motivated and focused.


Course Outline

Chapter 1: Introduction to ISO 14155

Topic 1.1: Overview of ISO 14155

  • Definition and purpose of ISO 14155
  • Scope and application of the standard
  • Key principles and requirements

Topic 1.2: History and Development of ISO 14155

  • Background and context of the standard
  • Development process and key milestones
  • Current status and future developments

Chapter 2: Principles of Clinical Trials

Topic 2.1: Introduction to Clinical Trials

  • Definition and purpose of clinical trials
  • Types of clinical trials and study designs
  • Key stakeholders and roles

Topic 2.2: Ethical Principles in Clinical Trials

  • Respect for persons and autonomy
  • Beneficence and non-maleficence
  • Justice and fairness

Chapter 3: Requirements of ISO 14155

Topic 3.1: General Requirements

  • Quality management system
  • Risk management
  • Documentation and record-keeping

Topic 3.2: Clinical Trial Planning and Design

  • Study protocol and design
  • Sample size calculation and statistical analysis
  • Selection and management of study sites

Chapter 4: Conducting Clinical Trials

Topic 4.1: Study Initiation and Start-up

  • Study site selection and initiation
  • Study participant recruitment and informed consent
  • Study data management and monitoring

Topic 4.2: Study Maintenance and Closure

  • Study site management and monitoring
  • Study participant follow-up and retention
  • Study closure and final reporting

Chapter 5: Auditing and Compliance

Topic 5.1: Auditing Principles and Requirements

  • Auditing objectives and scope
  • Auditing methods and techniques
  • Auditing reporting and follow-up

Topic 5.2: Compliance with ISO 14155

  • Compliance with regulatory requirements
  • Compliance with industry standards and guidelines
  • Maintaining compliance and continuous improvement

Chapter 6: Implementation and Maintenance

Topic 6.1: Implementing ISO 14155 in an Organization

  • Gap analysis and implementation planning
  • Training and awareness programs
  • Documentation and record-keeping

Topic 6.2: Maintaining and Improving the Quality Management System

  • Continuous monitoring and evaluation
  • Corrective and preventive actions
  • Management review and improvement

Chapter 7: Case Studies and Practical Applications

Topic 7.1: Case Study 1 - Implementing ISO 14155 in a Medical Device Company

  • Background and context
  • Implementation process and challenges
  • Lessons learned and best practices

Topic 7.2: Case Study 2 - Conducting,

!