Skip to main content
Mastering ISO 14155; Regulatory Compliance for Medical Device Clinical Trials

Mastering ISO 14155; Regulatory Compliance for 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
Toolkit Included:
Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
Adding to cart… The item has been added

Mastering ISO 14155: Regulatory Compliance for Medical Device Clinical Trials



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of the regulatory requirements for medical device clinical trials, as outlined in ISO 14155. Through interactive and engaging lessons, participants will gain the knowledge and skills necessary to ensure compliance with regulatory standards and successfully manage clinical trials.



Course Objectives

  • Understand the regulatory framework for medical device clinical trials
  • Interpret and apply the requirements of ISO 14155
  • Develop a comprehensive understanding of clinical trial design and management
  • Ensure compliance with regulatory standards and Good Clinical Practice (GCP)
  • Manage clinical trial data and documentation effectively
  • Prepare for regulatory audits and inspections


Course Outline

Module 1: Introduction to ISO 14155 and Regulatory Compliance

  • Overview of ISO 14155 and its importance in medical device clinical trials
  • Regulatory framework for medical device clinical trials
  • Understanding the role of regulatory authorities and sponsor responsibilities

Module 2: Clinical Trial Design and Management

  • Clinical trial design and protocol development
  • Investigator selection and site management
  • Clinical trial monitoring and data management
  • Risk management and safety reporting

Module 3: Regulatory Requirements for Clinical Trials

  • Informed consent and patient recruitment
  • Clinical trial documentation and record-keeping
  • Regulatory reporting and compliance
  • Good Clinical Practice (GCP) and quality assurance

Module 4: Data Management and Statistical Analysis

  • Data management and data quality assurance
  • Statistical analysis and data interpretation
  • Clinical trial reporting and publication
  • Data protection and confidentiality

Module 5: Regulatory Audits and Inspections

  • Preparing for regulatory audits and inspections
  • Understanding audit and inspection procedures
  • Responding to audit and inspection findings
  • Corrective and preventive action (CAPA)

Module 6: ISO 14155 and GCP Compliance

  • Understanding ISO 14155 and GCP requirements
  • Implementing ISO 14155 and GCP in clinical trials
  • Ensuring compliance with ISO 14155 and GCP
  • Auditing and monitoring for ISO 14155 and GCP compliance

Module 7: Clinical Trial Ethics and Patient Safety

  • Clinical trial ethics and patient safety principles
  • Informed consent and patient recruitment
  • Risk management and safety reporting
  • Clinical trial monitoring and data management

Module 8: Clinical Trial Project Management

  • Clinical trial project management principles
  • Project planning and budgeting
  • Project execution and monitoring
  • Project closure and evaluation

Module 9: Clinical Trial Quality Assurance

  • Clinical trial quality assurance principles
  • Quality planning and quality control
  • Quality assurance and quality improvement
  • Auditing and monitoring for quality assurance

Module 10: Clinical Trial Regulatory Update

  • Regulatory updates and changes in clinical trial regulations
  • Impact of regulatory changes on clinical trials
  • Strategies for implementing regulatory changes
  • Best practices for staying up-to-date with regulatory changes


Certificate of Completion

Upon completion of this course, participants will receive a Certificate of Completion issued by The Art of Service.



Course Features

  • Interactive and engaging lessons
  • Comprehensive and up-to-date content
  • Expert instructors with industry experience
  • Personalized learning experience
  • Flexible learning format (online, self-paced)
  • Mobile-accessible and user-friendly platform
  • Community-driven discussion forum
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking


Who Should Take This Course?

  • Clinical trial managers and coordinators
  • Regulatory affairs professionals
  • Quality assurance professionals
  • Clinical research associates
  • Medical device industry professionals
  • Pharmaceutical industry professionals
  • Biotechnology industry professionals
  • Anyone involved in clinical trials and regulatory compliance
,
!