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About This Webinar
ISO 14155 is the international standard for good clinical practice (GCP) in clinical investigations of medical devices for human subjects. The recent updates to this standard have significant implications for manufacturers seeking CE marking under the EU MDR.
This webinar provides comprehensive guidance on navigating the key changes to ISO 14155, ensuring your clinical investigations meet the highest standards of quality, safety, and regulatory compliance.
Key Topics Covered
Overview of ISO 14155 Updates
Comprehensive review of the latest amendments and their impact on clinical investigation planning and execution.
Risk-Based Approach to Clinical Investigations
How to implement a risk-based methodology in study design, monitoring, and data management under the new ISO 14155 requirements.
Protocol Development & Ethics
Best practices for developing robust clinical investigation protocols that align with ISO 14155 and EU MDR expectations.
Data Integrity & Documentation
Ensuring data quality, traceability, and compliance with updated documentation requirements for notified body submissions.
Investigator Responsibilities
Understanding the evolving roles and responsibilities of investigators, sponsors, and monitors under ISO 14155.
CE Marking Pathway
How compliant clinical investigations under ISO 14155 support successful CE marking applications and notified body approvals.
Key Takeaways
Understand the critical updates to ISO 14155 and how they impact your clinical investigation strategy and CE marking pathway.
Learn how to implement a risk-based approach to clinical investigations that aligns with both ISO 14155 and EU MDR requirements.
Master protocol development best practices that ensure regulatory compliance and successful notified body submissions.
Ensure data integrity and documentation quality throughout the clinical investigation lifecycle with updated ISO 14155 standards.
Clarify investigator and sponsor responsibilities under the new ISO 14155 framework to avoid compliance pitfalls.
Gain practical insights from real-world case studies demonstrating successful ISO 14155-compliant clinical investigations.
Who Should Watch This Webinar?
This webinar is designed for medical device manufacturers, regulatory affairs professionals, clinical operations managers, quality assurance teams, and anyone involved in planning or executing clinical investigations under the EU MDR.
Whether you're transitioning from MDD to MDR, planning your first ISO 14155-compliant study, or seeking to optimize your existing clinical investigation processes, this webinar provides actionable insights and expert guidance.
Need Expert Support for Your Clinical Investigation?
Partner with Eclevar MedTech for ISO 14155-compliant clinical investigations that drive CE marking success.
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