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Mastering ISO 14155; Clinical Investigations of Medical Devices

Mastering ISO 14155; Clinical Investigations of Medical Devices

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Mastering ISO 14155: Clinical Investigations of Medical Devices

Mastering ISO 14155: Clinical Investigations of Medical Devices

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 investigations of medical devices.



Course Overview

This course is interactive, engaging, comprehensive, personalized, up-to-date, practical, and features real-world applications. Our expert instructors will guide you through the course material, and upon completion, you will receive a certificate issued by The Art of Service.



Course Features

  • Interactive: Engage with the course material through interactive lessons and activities.
  • Engaging: Learn through real-world examples and case studies.
  • Comprehensive: Cover all aspects of ISO 14155, including clinical investigation planning, conduct, and reporting.
  • Personalized: Receive personalized feedback and support from our expert instructors.
  • Up-to-date: Stay current with the latest developments and updates to the standard.
  • Practical: Apply your knowledge through hands-on projects and activities.
  • Real-world applications: Learn how to apply the principles of ISO 14155 in real-world scenarios.
  • High-quality content: Access high-quality course materials, including video lessons, readings, and activities.
  • Expert instructors: Learn from experienced instructors with expertise in clinical investigations and medical devices.
  • Certification: Receive a certificate upon completion, issued by The Art of Service.
  • Flexible learning: Access the course materials at any time, from any location.
  • User-friendly: Navigate the course materials with ease, using our user-friendly online platform.
  • Mobile-accessible: Access the course materials on your mobile device, at any time.
  • Community-driven: Connect with other participants and instructors through our online community.
  • Actionable insights: Gain actionable insights and knowledge that you can apply in your work.
  • Hands-on projects: Apply your knowledge through hands-on projects and activities.
  • Bite-sized lessons: Learn through bite-sized lessons, designed to fit your busy schedule.
  • Lifetime access: Access the course materials for a lifetime, at no additional cost.
  • Gamification: Engage with the course material through interactive games and activities.
  • Progress tracking: Track your progress through the course, and receive feedback on your performance.


Course Outline

Module 1: Introduction to ISO 14155

  • Overview of ISO 14155
  • History and development of the standard
  • Scope and applicability of the standard
  • Key principles and requirements

Module 2: Clinical Investigation Planning

  • Defining the clinical investigation question
  • Developing the clinical investigation plan
  • Identifying the target population
  • Selecting the clinical investigation sites

Module 3: Clinical Investigation Conduct

  • Initiating the clinical investigation
  • Conducting the clinical investigation
  • Managing clinical investigation data
  • Ensuring participant safety

Module 4: Clinical Investigation Reporting

  • Developing the clinical investigation report
  • Presenting the results
  • Interpreting the results
  • Submitting the report

Module 5: Clinical Investigation Monitoring and Auditing

  • Monitoring the clinical investigation
  • Conducting audits
  • Identifying and addressing non-compliance
  • Maintaining records

Module 6: Clinical Investigation Ethics and Informed Consent

  • Understanding clinical investigation ethics
  • Developing informed consent materials
  • Obtaining informed consent
  • Maintaining participant confidentiality

Module 7: Clinical Investigation Regulations and Standards

  • Overview of regulatory requirements
  • Understanding ISO 14155 and other relevant standards
  • Compliance with regulations and standards
  • Maintaining records

Module 8: Clinical Investigation Quality Management

  • Understanding quality management principles
  • Developing a quality management plan
  • Implementing quality management procedures
  • Maintaining records

Module 9: Clinical Investigation Risk Management

  • Understanding risk management principles
  • Identifying and assessing risks
  • Developing risk mitigation strategies
  • Maintaining records

Module 10: Clinical Investigation Case Studies

  • Real-world examples of clinical investigations
  • Applying ISO 14155 principles in practice
  • Lessons learned and best practices
  • Group discussion and feedback


Certification

Upon completion of the course, participants will receive a certificate issued by The Art of Service.

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