WEBINAR REPLAY March 25, 2025: Navigating Key Updates to ISO 14155: Driving Clinical Evidence for CE Marking Success
Leading medical device teams work with Eclevar
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.
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.
A European team of former notified body reviewers
The people who build your evidence have sat on the other side of the table.
Dr Mark Da Costa
Dr Nikhil Khadabadi
Pierre-Marie BoutanquoiQuestions sponsors ask first
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.
Partner with Eclevar MedTech for ISO 14155-compliant clinical investigations that drive CE marking success.
Our content, signed Eclevar.
Whitepapers and publications produced by our teams with our notified body partners.
A BSI and Eclevar whitepaper on the EU MDR.
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, the same evidence your file has to support.
Related pages
The services and topics connected to this page.
Tell us where your evidence stands today
Send us the device, the claim and the deadline. You get a written answer within 24 hours.
Your documents are reviewed confidentially. An NDA can be signed before we receive any technical or clinical information.