ISO 14155 FDIS 2025 Revision
ISO 14155 FDIS 2025 Revision
This course is brought to you by Danielle Giroud, the convenor of the TC 194 Working group 4 responsible for the ISO 14155 updates. The course provides a complete and comprehensive overview of important changes applied in the FDIS (Final Draft International Standard) ISO 14155 on Clinical investigation of medical devices for human subjects — Good clinical practice. Important changes in risk management, safety considerations, statistical considerations, ethics and informed consent requirements and many others have been introduced and are covered in detail and practical manner.
The update is focusing on the changes only, thereby a practical approach in getting your certifications up to date without going through the whole standard again. Learn directly from the source, Danielle Giroud convenor of the Working Group, not only about new things but why these requirements are introduced or changed to give you a full in depth understanding.
ID: N351
61 minutes
2 modules
Learning Objectives:
The objective of this course is to enable you to stay up to date with the ISO 14155 standard and the important changes applied in this 2025 version.
Staying informed about the ISO 14155 standard will allow you to align and update your internal processes and systems in compliance with the latest requirements.
Who Should Enroll:
Anyone with a current ISO 14155:2020 or older certificate requiring a recertification according to this important update.
Prerequisite Knowledge:
ISO 14155 prior version knowledge is required.