ISO 14155:2020 – Good Clinical Practice for Medical Devices (GCP)

Comprehensive Hands-On Training for Planning, Conducting, and Documenting Clinical Investigations in Compliance with MDR

Navigating the complexities of ISO 14155 can be daunting. This course breaks down the ISO-standard into actionable steps, providing you with the knowledge and tools needed to effectively plan, execute, and document clinical investigations for medical devices. Through real-world examples and case studies, you will gain practical insights that are directly applicable to your work.

Course description

This course provides a comprehensive overview of clinical investigations according to ISO 14155, covering the entire process from study design and execution to documentation and compliance with MDR requirements. It is designed for professionals involved in the development or manufacturing of medical devices, as well as clinical staff such as investigators, research nurses, and clinical study coordinators who need to understand how to conduct and gather clinical data through the study. Starting with foundational concepts, the course delves into detailed, practical guidance on planning, conducting, and documenting investigations according to ISO 14155. Upon completion, you will be equipped to ask relevant questions, assess the required level of data quality, and integrate clinical investigation findings seamlessly within your technical documentation.

Course outline (2 x half day)

• Foundations of ISO 14155: Establish fundamental knowledge of ISO 14155, including its scope, ethical considerations, regulatory framework, and key stakeholder roles.
• Planning the Clinical Investigation: Learn how to design and plan a compliant clinical investigation in line with ISO 14155.
• Clinical Roles and Responsibilities: Defining and clarifying common roles such as investigators, research nurses, study coordinators, Contract Research Organization (CRO), Sponsors and CRAs.
• Study Conduct and Monitoring: Comprehensive guidance on each phase of clinical investigations, covering site initiation, data collection and close-out. Understand how to conduct, monitor and manage a clinical investigation with full compliance.
• Analysis, Reporting & Post-Market Considerations: Develop skills for analyzing and reporting data, and managing post-market follow-up.
• Practical Tips and Key Focus Areas: Proven strategies for enhancing study quality, ensuring compliance, and mitigating common challenges.
• Case Studies to Solidify Your Knowledge: Real-world scenarios to demonstrate application of ISO 14155 principles and enhance learning.

Learning objectives

• Designing Compliant Clinical Investigations: Learn how to design clinical investigations based on clinical evaluation needs following ISO 14155 and MDR requirements.
• Effective Data Collection and Management: Acquire skills to collect, manage, and report clinical data effectively, from initiation visits to reporting.
• Comprehensive Understanding of Clinical Roles: Gain clarity on roles and responsibilities across the study team, including investigator and Sponsor oversight, documentation management, and ensuring compliance with ISO 14155 from a clinical perspective.
• Creating Key Study Documents: Develop and review essential documents such as Clinical Investigation Plan (CIP), Investigator’s Brochure (IB), and Case Report Forms (CRF)., avoiding common pitfalls.
• Quality Control and Oversight: Implement quality control measures, systematic study document review through monitoring, and ensure alignment with regulatory requirements.
• Applying Practical Knowledge: Enhance your skills through case studies and hands-on training that solidify your understanding of the ISO 14155 process.

Who should attend

This course is designed for professionals working in the development or manufacturing of medical devices, sponsors, monitors, as well as clinical staff including investigators, research nurses, and clinical study coordinators who need to understand how to conduct and document clinical investigations according to ISO 14155 and MDR requirements.

Prerequisites

A minimum of 1 year of experience in the medical device/IVD field or related life science sectors.

Access to the ISO 14155:2020 standard is recommended to enhance understanding and practical application during the course.

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