BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//iceps-mdivd - ECPv6.17.1//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://iceps-mdivd.org
X-WR-CALDESC:Events for iceps-mdivd
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:Europe/Brussels
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20270328T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20271031T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20261029T143000
DTEND;TZID=Europe/Brussels:20261029T153000
DTSTAMP:20261008T123637Z
CREATED:20260821T102058Z
LAST-MODIFIED:20261008T123637Z
UID:10000011-1793284200-1793287800@iceps-mdivd.org
SUMMARY:Live Q&A Session on the New ISO 18969 with Danielle Giroud
DESCRIPTION:Your Questions on the New Clinical Evaluation Standard — Answered by the ISO Working Group Convenor \nDate: 29 October 2026 | Time: 14:00 CET\nFormat: Online Session (Zoom) \nThe 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. \nWith 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? \nThis 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. \nThe 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. \nTake 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. \nSpeakers\nDanielle Giroud\nFounder\, CEO\, MD-Clinicals & WMDO. \nWith 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. \nMs. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO). \nSince 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. \n  \nPractical Information\n\nDate: 29 October 2026\nTime: 14:00–15:30 CET\nDuration: 1 hour 30 minutes\nFormat: Online via Zoom\nRegistration Fee: Free for ICEPS members and 20€ for non-members (VAT excl.)\nZoom Access: The Zoom link and connection details will be sent by email.\nRecording: The session will be recorded\, and access to it will be only for ICEPS members.\n\nImportant Information\nPlease note that this event is a webinar only. \nParticipants will have the opportunity to ask questions and exchange directly with the expert speaker. \nThis session is not a training course\, and participation does not provide a certificate of attendance\, training completion\, or certification. \nYour Zoom access link is personal and may not be shared. Any participant not registered through ICEPS may be removed from the webinar without notice. \nThe session is recorded and only available for ICEPS members. \n 
URL:https://iceps-mdivd.org/event/live-qa-session-on-the-new-iso-18969-with-danielle-giroud/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/08/261029-QA-ISO-18969-1.png
END:VEVENT
END:VCALENDAR