What does the ISO 14155 Masterclass course cover?
ISO 14155 Masterclass is covered here in 15 modules: Introduction to ISO 14155: Key principles and requirements, Clinical Investigation Planning: Identifying the investigation site, Clinical Investigation Design: Sample size calculation, Randomization and blinding and 12 more. The outline lists 59 specific topics, opening with overview of ISO 14155 and its importance and closing with confidentiality and data protection.
How do you approach ISO 14155 Masterclass step by step?
The work is sequenced in 15 stages. It starts with introduction to ISO 14155: Key principles and requirements, moves through Clinical Investigation Planning: Identifying the investigation site and Clinical Investigation Design: Sample size calculation, Randomization and blinding, and ends at Clinical Investigation Ethics: Ethical principles and guidelines. Each stage carries its own topic list, so the sequence is followed rather than summarised.
What is in Module 1 of the ISO 14155 Masterclass course?
Module 1 is Introduction to ISO 14155: Key principles and requirements. It works through overview of ISO 14155 and its importance, history and development of the standard and key principles and requirements. It sets the vocabulary the remaining 14 modules build on.
How is the ISO 14155 Masterclass course delivered?
The ISO 14155 Masterclass course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.
How much does the ISO 14155 Masterclass course cost?
The ISO 14155 Masterclass course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.
Closely related courses: Expert Guidance in Privacy Issues Kit, Restructuring Strategies, CCISO Masterclass, MISRA C.
More answers: what you get with every course, refund policy, all help answers.
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: Key principles and requirements
- Overview of ISO 14155 and its importance
- History and development of the standard
- Key principles and requirements
Module 2. Clinical Investigation Planning: Identifying the investigation site
- Defining the clinical investigation plan
- Establishing the investigation team
- Identifying the investigation site
- Determining the investigation timeline
Module 3. Clinical Investigation Design: Sample size calculation, Randomization and blinding
- Types of clinical investigation designs
- Randomization and blinding
- Sample size calculation
- Data collection and management
Module 4. Clinical Investigation Conduct: Conducting the investigation
- Initiating the clinical investigation
- Conducting the investigation
- Managing investigation site personnel
- Monitoring and reporting adverse events
Module 5. Clinical Investigation Monitoring: Conducting site visits, Reviewing investigation data
- Monitoring the clinical investigation
- Conducting site visits
- Reviewing investigation data
- Identifying and addressing deviations
Module 6. Clinical Investigation Close-out: Submitting the final report
- Completing the clinical investigation
- Documenting investigation results
- Reporting investigation findings
- Submitting the final report
Module 7. Clinical Investigation Reporting: Writing the report, Finalizing the report
- Preparing the clinical investigation report
- Writing the report
- Reviewing and editing the report
- Finalizing the report
Module 8. Regulatory Requirements: US FDA requirements, EU MDR and IVDR requirements
- Overview of regulatory requirements
- EU MDR and IVDR requirements
- US FDA requirements
- Other international regulatory requirements
Module 9. Quality Management: ISO 13485 and systems, Quality planning and control
- Introduction to quality management
- ISO 13485 and quality management systems
- Quality planning and control
- Quality assurance and auditing
Module 10. Risk Management: ISO 14971 and, Risk mitigation and control
- 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: Audit planning and conduct, Audit reporting and follow-up
- 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: Training planning and conduct
- Introduction to clinical investigation training
- Training planning and conduct
- Training evaluation and assessment
- Training documentation and record-keeping
Module 15. Clinical Investigation Ethics: Ethical principles and guidelines
- 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