ISO 14155 Clinical Investigation of Medical Devices Training by Tonex
Tonex’s “ISO 14155 Clinical Investigation of Medical Devices” training is a comprehensive program designed to provide in-depth knowledge and practical insights into the requirements and principles outlined in ISO 14155. This course is tailored for professionals involved in the clinical investigation of medical devices, ensuring compliance with international standards and regulatory frameworks.
Tonex’s “ISO 14155 Clinical Investigation of Medical Devices” training offers a comprehensive understanding of the international standards governing medical device clinical investigations. This course equips professionals with the knowledge to navigate ISO 14155, addressing key principles, regulatory landscapes, and ethical considerations. Participants will gain practical insights into study design, planning, and effective execution of clinical trials, ensuring compliance with global regulatory frameworks.
With a focus on data collection, documentation, and patient safety, this training enhances proficiency in managing every aspect of medical device clinical investigations. Ideal for clinical research professionals, regulatory affairs specialists, and anyone involved in ensuring the quality and integrity of clinical trials.
Learning Objectives:
- Gain a thorough understanding of ISO 14155 and its implications for clinical investigations.
- Master the key principles and requirements for the design and conduct of medical device clinical studies.
- Learn how to navigate regulatory challenges and ensure compliance throughout the clinical investigation process.
- Acquire skills to effectively plan, execute, and monitor clinical trials in accordance with ISO 14155.
- Enhance proficiency in documentation and reporting, meeting the highest standards of quality and integrity.
- Develop strategies for addressing ethical considerations and patient safety in medical device clinical investigations.
Audience: This course is ideal for:
- Clinical Research Professionals
- Regulatory Affairs Specialists
- Medical Device Developers and Engineers
- Quality Assurance and Compliance Personnel
- Clinical Investigators and Research Coordinators
- Professionals involved in the planning and execution of medical device clinical trials
Course Outline:
Module 1: Introduction to ISO 14155
- ISO 14155 Overview
- Significance in Medical Device Clinical Investigations
- Evolution of ISO 14155 Standards
- Purpose and Scope of ISO 14155
- Key Terms and Definitions
- Overview of Changes in Recent Versions
Module 2: Regulatory Landscape
- Global Regulatory Frameworks
- Impact of ISO 14155 on Regulatory Compliance
- Harmonization with Other Regulatory Standards
- Regulatory Challenges in Medical Device Clinical Studies
- Key Regulatory Authorities and their Requirements
- Updates on Recent Regulatory Changes
Module 3: Study Design and Planning
- Principles of Study Design
- Planning Clinical Investigations
- Risk Assessment and Management
- Determining Sample Size and Statistical Considerations
- Selecting Investigational Sites
- Preparing Investigator’s Brochure
Module 4: Conducting Clinical Trials
- Site Initiation and Training
- Patient Recruitment and Informed Consent
- Data Collection Tools and Techniques
- Monitoring and Quality Assurance
- Adverse Event Reporting
- Managing Investigational Product
Module 5: Data Collection and Documentation
- Case Report Form (CRF) Development
- Data Collection and Entry
- Data Quality and Integrity
- Source Documentation
- Electronic Data Capture (EDC) Systems
- Handling and Storage of Clinical Data
Module 6: Ethical Considerations and Patient Safety
- Informed Consent Process
- Institutional Review Board (IRB) Approval
- Protection of Vulnerable Populations
- Monitoring for Adverse Events
- Data Safety Monitoring Boards (DSMB)
- Ensuring Continuous Patient Safety throughout the Study