Mastering ISO 14155: A Step-by-Step Guide to Medical Device Clinical Investigations

Course Overview

This comprehensive course provides a step-by-step guide to medical device clinical investigations, ensuring that you master the requirements of ISO 14155. Participants will receive a certificate upon completion, issued by The Art of Service.

Course Features

• Interactive and engaging content
• Comprehensive and personalized learning experience
• Up-to-date and practical information
• Real-world applications and case studies
• High-quality content developed by expert instructors
• Certification upon completion
• Flexible learning options, including mobile accessibility
• User-friendly interface and community-driven discussions
• Actionable insights and hands-on projects
• Bite-sized lessons and lifetime access
• Gamification and progress tracking features

Course Outline

Module 1: Introduction to ISO 14155

• Overview of ISO 14155 and its importance in medical device clinical investigations
• History and development of the standard
• Key concepts and terminology
• Relationship with other standards and regulations

Module 2: Clinical Investigation Planning

• Defining the clinical investigation objective and scope
• Identifying the target population and selection criteria
• Determining the sample size and statistical analysis
• Developing a clinical investigation plan and protocol
• Establishing a data management plan

Module 3: Clinical Investigation Design

• Types of clinical investigation designs (e.g., randomized controlled trials, observational studies)
• Control groups and comparator selection
• Blinding and masking techniques
• Randomization and stratification methods
• Crossover and parallel study designs

Module 4: Clinical Investigation Conduct

• Initiating the clinical investigation (e.g., site selection, investigator training)
• Conducting the clinical investigation (e.g., participant recruitment, data collection)
• Managing clinical investigation sites and personnel
• Maintaining participant safety and well-being
• Handling adverse events and serious adverse events

Module 5: Clinical Investigation Monitoring

• Defining monitoring responsibilities and requirements
• Conducting on-site monitoring visits
• Remote monitoring and centralized monitoring techniques
• Identifying and addressing monitoring findings
• Maintaining monitoring records and reports

Module 6: Clinical Investigation Data Management

• Data collection and data entry procedures
• Data validation and data cleaning techniques
• Data analysis and statistical methods
• Data storage and data security measures
• Data sharing and data publication guidelines

Module 7: Clinical Investigation Reporting

• Developing a clinical investigation report
• Writing a clinical investigation summary and conclusions
• Creating tables, figures, and graphs
• Documenting adverse events and serious adverse events
• Finalizing the clinical investigation report

Module 8: Clinical Investigation Close-out

• Conducting a close-out visit
• Documenting close-out activities
• Ensuring participant follow-up and post-study care
• Maintaining study records and reports
• Reviewing and evaluating the clinical investigation

Module 9: ISO 14155 and Regulatory Compliance

• Overview of regulatory requirements for medical device clinical investigations
• ISO 14155 and EU MDR compliance
• ISO 14155 and FDA compliance
• Other regulatory requirements and guidelines
• Maintaining compliance throughout the clinical investigation

Module 10: Audits and Inspections

• Preparing for audits and inspections
• Conducting internal audits and self-assessments
• Hosting external audits and inspections
• Addressing audit and inspection findings
• Implementing corrective actions and preventive actions

Module 11: Risk Management and Quality Assurance

• Identifying and assessing risks in medical device clinical investigations
• Developing and implementing risk mitigation strategies
• Establishing a quality assurance program
• Conducting quality control activities
• Maintaining quality assurance and quality control records

Module 12: Ethics and Informed Consent

• Principles of ethics in medical device clinical investigations
• Informed consent requirements and procedures
• Developing and reviewing informed consent forms
• Ensuring participant understanding and comprehension
• Maintaining informed consent records

Module 13: Clinical Investigation Personnel and Training

• Defining clinical investigation personnel roles and responsibilities
• Developing and implementing training programs
• Conducting training sessions and evaluations
• Maintaining training records and documentation
• Ensuring ongoing training and professional development

Module 14: Vendor Management and Outsourcing

• Defining vendor management and outsourcing requirements
• Selecting and qualifying vendors
• Developing and implementing vendor management plans
• Conducting vendor audits and assessments
• Maintaining vendor management records and reports

Module 15: Electronic Data Capture and Clinical Data Management Systems

• Overview of electronic data capture (EDC) systems
• Clinical data management system (CDMS) requirements
• Developing and implementing EDC and CDMS plans
• Conducting EDC and CDMS training and support
• Maintaining EDC and CDMS records and reports

Certificate and Continuing Education

Upon completion of the course, participants will receive a certificate issued by The Art of Service. The course also provides continuing education credits and professional development opportunities.

,