International Clinical Evidence Professional Society, the global leader in the development of innovative approaches to evidence harmonization for medical devices and in-vitro diagnostics.
ISO 14155:2026 – Risk Management for Clinical Investigations
July 9 @ 2:00 pm - 3:30 pm
€15.00
Live Q&A Session with Danielle Giroud
Date: 9 July 2026 | Time: 14:00 CET
Format: Online Session (Zoom)
The publication of ISO 14155:2026 introduces significant updates to risk management and the conduct of clinical investigations. Understanding how to interpret and implement these new requirements can be challenging for manufacturers, sponsors, CROs, investigators, and quality and regulatory professionals.
Join Danielle Giroud, Convenor of ISO/TC 194 Working Group 4, for an exclusive live Q&A session dedicated to the practical implementation of the new standard. This session provides a unique opportunity to gain clarification directly from one of the experts involved in the development of ISO 14155:2026.
Participants will have the opportunity to discuss practical implementation challenges, ask questions about specific requirements, and better understand how to apply the updated expectations within their organizations.
In Collaboration with WMDO
This session is organized in collaboration with the World Medical Device Organization (WMDO), which offers dedicated training courses on ISO 14155:2026:
Participants who have completed one of these WMDO training courses may attend this Q&A session free of charge and do not need to register separately.
What Participants Learn in the WMDO Courses
The WMDO training courses provide practical guidance on how to:
- Translate ISO 14155:2026 requirements into real-world clinical investigation practice.
- Understand regulatory expectations and maintain compliance across global markets.
- Structure, plan, and manage clinical investigations with confidence.
- Align documentation, processes, and teams with the updated standard.
- Reduce risk and ensure inspection-ready compliance.
- Implement the enhanced risk management processes introduced in ISO 14155:2026.
This Q&A session complements the training courses by providing an opportunity to discuss specific questions and implementation challenges directly with a leading expert.
Submit Your Questions
Participants are encouraged to submit their questions in advance to:
Questions received before the session will help shape the discussion and ensure that key implementation challenges and practical concerns are addressed during the live event.
Practical Information
- Date: 9 July 2026
- Time: 14:00–15:30 CET
- Duration: 1 hour 30 minutes
- Format: Online via Zoom
- Registration Fee: €15 per participant
- Free Access: Participants who have completed one of the WMDO ISO 14155:2026 training courses may attend free of charge.
- Zoom Access: The Zoom link and connection details will be sent by email to all participants one day before the event.
- Recording: The session will not be recorded.
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 ISO 14155:2026 and its risk management requirements. 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.