ISO 14155 Masterclass: Expert Guidance on Clinical Investigations of Medical Devices
Certificate Upon Completion Participants receive a certificate upon completion issued by The Art of Service.
Course Overview This comprehensive course provides expert guidance on clinical investigations of medical devices, covering the principles and requirements of ISO 14155. Through interactive and engaging lessons, participants will gain a deep understanding of the standard and its application in real-world scenarios.
Course Features - Interactive and engaging content
- Comprehensive coverage of ISO 14155
- Personalized learning experience
- Up-to-date information and practical applications
- High-quality content developed by expert instructors
- Certification upon completion
- Flexible learning options
- User-friendly interface
- Mobile-accessible
- Community-driven learning environment
- Actionable insights and hands-on projects
- Bite-sized lessons for easy learning
- Lifetime access to course materials
- Gamification and progress tracking features
Course Outline Module 1: Introduction to ISO 14155
- Overview of ISO 14155 and its importance
- History and development of the standard
- Key principles and requirements
Module 2: Clinical Investigation Planning
- Defining the clinical investigation plan
- Establishing the investigation team
- Identifying the investigation site
- Determining the investigation timeline
Module 3: Clinical Investigation Design
- Types of clinical investigation designs
- Randomization and blinding
- Sample size calculation
- Data collection and management
Module 4: Clinical Investigation Conduct
- Initiating the clinical investigation
- Conducting the investigation
- Managing investigation site personnel
- Monitoring and reporting adverse events
Module 5: Clinical Investigation Monitoring
- Monitoring the clinical investigation
- Conducting site visits
- Reviewing investigation data
- Identifying and addressing deviations
Module 6: Clinical Investigation Close-out
- Completing the clinical investigation
- Documenting investigation results
- Reporting investigation findings
- Submitting the final report
Module 7: Clinical Investigation Reporting
- Preparing the clinical investigation report
- Writing the report
- Reviewing and editing the report
- Finalizing the report
Module 8: Regulatory Requirements
- Overview of regulatory requirements
- EU MDR and IVDR requirements
- US FDA requirements
- Other international regulatory requirements
Module 9: Quality Management
- Introduction to quality management
- ISO 13485 and quality management systems
- Quality planning and control
- Quality assurance and auditing
Module 10: Risk Management
- Introduction to risk management
- ISO 14971 and risk management
- Risk assessment and analysis
- Risk mitigation and control
Module 11: Clinical Evaluation
- Introduction to clinical evaluation
- Clinical evaluation planning
- Clinical evaluation conduct
- Clinical evaluation reporting
Module 12: Post-Market Surveillance
- Introduction to post-market surveillance
- Post-market surveillance planning
- Post-market surveillance conduct
- Post-market surveillance reporting
Module 13: Clinical Investigation Auditing
- Introduction to clinical investigation auditing
- Audit planning and conduct
- Audit reporting and follow-up
- Audit corrective action and preventive action
Module 14: Clinical Investigation Training
- Introduction to clinical investigation training
- Training planning and conduct
- Training evaluation and assessment
- Training documentation and record-keeping
Module 15: Clinical Investigation Ethics
- Introduction to clinical investigation ethics
- Ethical principles and guidelines
- Informed consent and patient rights
- Confidentiality and data protection
Certification Upon completion of the course, participants will receive a certificate issued by The Art of Service.
Target Audience This course is designed for professionals involved in clinical investigations of medical devices, including: - Clinical investigation managers
- Clinical investigation coordinators
- Clinical investigation monitors
- Clinical investigation auditors
- Regulatory affairs professionals
- Quality management professionals
- Risk management professionals
- Clinical evaluation professionals
- Post-market surveillance professionals
,
Course Features - Interactive and engaging content
- Comprehensive coverage of ISO 14155
- Personalized learning experience
- Up-to-date information and practical applications
- High-quality content developed by expert instructors
- Certification upon completion
- Flexible learning options
- User-friendly interface
- Mobile-accessible
- Community-driven learning environment
- Actionable insights and hands-on projects
- Bite-sized lessons for easy learning
- Lifetime access to course materials
- Gamification and progress tracking features
Course Outline Module 1: Introduction to ISO 14155
- Overview of ISO 14155 and its importance
- History and development of the standard
- Key principles and requirements
Module 2: Clinical Investigation Planning
- Defining the clinical investigation plan
- Establishing the investigation team
- Identifying the investigation site
- Determining the investigation timeline
Module 3: Clinical Investigation Design
- Types of clinical investigation designs
- Randomization and blinding
- Sample size calculation
- Data collection and management
Module 4: Clinical Investigation Conduct
- Initiating the clinical investigation
- Conducting the investigation
- Managing investigation site personnel
- Monitoring and reporting adverse events
Module 5: Clinical Investigation Monitoring
- Monitoring the clinical investigation
- Conducting site visits
- Reviewing investigation data
- Identifying and addressing deviations
Module 6: Clinical Investigation Close-out
- Completing the clinical investigation
- Documenting investigation results
- Reporting investigation findings
- Submitting the final report
Module 7: Clinical Investigation Reporting
- Preparing the clinical investigation report
- Writing the report
- Reviewing and editing the report
- Finalizing the report
Module 8: Regulatory Requirements
- Overview of regulatory requirements
- EU MDR and IVDR requirements
- US FDA requirements
- Other international regulatory requirements
Module 9: Quality Management
- Introduction to quality management
- ISO 13485 and quality management systems
- Quality planning and control
- Quality assurance and auditing
Module 10: Risk Management
- Introduction to risk management
- ISO 14971 and risk management
- Risk assessment and analysis
- Risk mitigation and control
Module 11: Clinical Evaluation
- Introduction to clinical evaluation
- Clinical evaluation planning
- Clinical evaluation conduct
- Clinical evaluation reporting
Module 12: Post-Market Surveillance
- Introduction to post-market surveillance
- Post-market surveillance planning
- Post-market surveillance conduct
- Post-market surveillance reporting
Module 13: Clinical Investigation Auditing
- Introduction to clinical investigation auditing
- Audit planning and conduct
- Audit reporting and follow-up
- Audit corrective action and preventive action
Module 14: Clinical Investigation Training
- Introduction to clinical investigation training
- Training planning and conduct
- Training evaluation and assessment
- Training documentation and record-keeping
Module 15: Clinical Investigation Ethics
- Introduction to clinical investigation ethics
- Ethical principles and guidelines
- Informed consent and patient rights
- Confidentiality and data protection
Certification Upon completion of the course, participants will receive a certificate issued by The Art of Service.
Target Audience This course is designed for professionals involved in clinical investigations of medical devices, including: - Clinical investigation managers
- Clinical investigation coordinators
- Clinical investigation monitors
- Clinical investigation auditors
- Regulatory affairs professionals
- Quality management professionals
- Risk management professionals
- Clinical evaluation professionals
- Post-market surveillance professionals
,
Module 1: Introduction to ISO 14155
- Overview of ISO 14155 and its importance
- History and development of the standard
- Key principles and requirements
Module 2: Clinical Investigation Planning
- Defining the clinical investigation plan
- Establishing the investigation team
- Identifying the investigation site
- Determining the investigation timeline
Module 3: Clinical Investigation Design
- Types of clinical investigation designs
- Randomization and blinding
- Sample size calculation
- Data collection and management
Module 4: Clinical Investigation Conduct
- Initiating the clinical investigation
- Conducting the investigation
- Managing investigation site personnel
- Monitoring and reporting adverse events
Module 5: Clinical Investigation Monitoring
- Monitoring the clinical investigation
- Conducting site visits
- Reviewing investigation data
- Identifying and addressing deviations
Module 6: Clinical Investigation Close-out
- Completing the clinical investigation
- Documenting investigation results
- Reporting investigation findings
- Submitting the final report
Module 7: Clinical Investigation Reporting
- Preparing the clinical investigation report
- Writing the report
- Reviewing and editing the report
- Finalizing the report
Module 8: Regulatory Requirements
- Overview of regulatory requirements
- EU MDR and IVDR requirements
- US FDA requirements
- Other international regulatory requirements
Module 9: Quality Management
- Introduction to quality management
- ISO 13485 and quality management systems
- Quality planning and control
- Quality assurance and auditing
Module 10: Risk Management
- Introduction to risk management
- ISO 14971 and risk management
- Risk assessment and analysis
- Risk mitigation and control
Module 11: Clinical Evaluation
- Introduction to clinical evaluation
- Clinical evaluation planning
- Clinical evaluation conduct
- Clinical evaluation reporting
Module 12: Post-Market Surveillance
- Introduction to post-market surveillance
- Post-market surveillance planning
- Post-market surveillance conduct
- Post-market surveillance reporting
Module 13: Clinical Investigation Auditing
- Introduction to clinical investigation auditing
- Audit planning and conduct
- Audit reporting and follow-up
- Audit corrective action and preventive action
Module 14: Clinical Investigation Training
- Introduction to clinical investigation training
- Training planning and conduct
- Training evaluation and assessment
- Training documentation and record-keeping
Module 15: Clinical Investigation Ethics
- Introduction to clinical investigation ethics
- Ethical principles and guidelines
- Informed consent and patient rights
- Confidentiality and data protection
Certification Upon completion of the course, participants will receive a certificate issued by The Art of Service.
Target Audience This course is designed for professionals involved in clinical investigations of medical devices, including: - Clinical investigation managers
- Clinical investigation coordinators
- Clinical investigation monitors
- Clinical investigation auditors
- Regulatory affairs professionals
- Quality management professionals
- Risk management professionals
- Clinical evaluation professionals
- Post-market surveillance professionals
,
- Clinical investigation managers
- Clinical investigation coordinators
- Clinical investigation monitors
- Clinical investigation auditors
- Regulatory affairs professionals
- Quality management professionals
- Risk management professionals
- Clinical evaluation professionals
- Post-market surveillance professionals