Your Questions on the New Clinical Evaluation Standard — Answered by the ISO Working Group Convenor

Date: 29 October 2026 | Time: 14:00 CET
Format: Online Session (Zoom)

The publication of ISO 18969, Clinical evaluation of medical devices, marks an important development for professionals involved in the clinical evaluation of medical devices. As a new international standard, ISO 18969 introduces principles and a structured process for planning and performing clinical evaluation throughout the medical device lifecycle.

With a new standard naturally come new questions: What does ISO 18969 mean in practice? How should its requirements and principles be interpreted? What should you consider when applying it to your clinical evaluation activities?

This live Q&A session is your opportunity to ask those questions directly to Danielle Giroud, Convenor of the ISO Working Group responsible for ISO 18969. Drawing on her first-hand involvement in the development of the standard, Danielle will address participants’ questions and provide insights into its principles, intent and practical application.

The session will be dedicated to your questions. Participants are encouraged to ask questions live during the event or submit them in advance when registering (support@iceps-mdivd.org). Whether there is a particular section of the standard you would like to better understand, a point you would like clarified, or a practical challenge you are already considering, this is the time to ask.

Take advantage of this opportunity to discuss the newly published ISO 18969 with someone directly involved in its development and gain a clearer understanding of what the new standard means for clinical evaluation in practice.

Speakers

Danielle Giroud
Founder, CEO, MD-Clinicals & WMDO.

With close to 40 years of experience, Ms. Danielle Giroud is an internationally recognized clinical research and regulatory expert within the global medical device industry. She has shared her extensive knowledge and experience with multi-national companies, organizations, and start-ups from around the world to help bring their products to market quickly and efficiently.

Ms. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO).

Since 2008 she is the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and clinical evaluation for the ISO 18969, and functions as a liaison with the EU Commission – Clinical Investigation and Evaluation, Performance Studies and Evaluation (CIEPSE) task force and other regulatory authorities throughout the world.

Practical Information

• Date: 29 October 2026
• Time: 14:00–15:30 CET
• Duration: 1 hour 30 minutes
• Format: Online via Zoom
• Registration Fee: €15 for ICEPS members and 35€ for non-members (VAT excl.)
• Zoom Access: The Zoom link and connection details will be sent by email.
• Recording: The session will be recorded, and access to it will be only for ICEPS members.

Important Information

Please note that this event is a live Question & Answer session only.

The purpose of the session is to provide clarification and discussion on the implementation of Estimands. Participants will have the opportunity to ask questions and exchange directly with the expert speaker.

This session is not a training course, and participation does not provide a certificate of attendance, training completion, or certification.

Your Zoom access link is personal and may not be shared. Any participant not registered through ICEPS may be removed from the webinar without notice.