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ISO TC 194 latest updates

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FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.

DATE: November 16, 2023 | 3.00 PM - 4.00 PM CET

OFFICIAL LANGUAGE: English

SUBMISSION LINK: https://attendee.gotowebinar.com/register/5371334637988412758

ATTENDEES CAPACITY: 500 delegates

The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.

Introduction
This webinar will provide post-meeting update for ISO TC 194 "Biological and clinical evaluation of medical devices". We'll be sharing the latest insights from our last meeting held in late October in Arlington, USA. It was an intense week with interesting discussions and proposals: chemical characterization, sample preparation, new in vitro models, risk assessment remain among the most debated among experts. New topics such as sustainability and the interactions between biological evaluation and stability have been introduced and discussed. Intensive work has been carried out on the draft (CD) of ISO 10993-1. Following engaging discussions and thanks to the contributions of a significant number of experts, the document is ready for a new round of comments. During the webinar, updates will be presented for the working groups that have convened, and the new developments we can expect in the ISO 10993 series will be discussed. We will also address “European matters” and how CEN TC 206 intends to contribute to the harmonization of standards under its responsibility.
Speaker

European Registered Toxicologist with a MSc in Applied Toxicology and Biomedical Engineering, Paolo has over 15 years of experience in biological evaluation of medical devices and toxicological risk assessment for pharmaceutical products. He is Senior Scientific Director at Eurofins Medical Device Testing Europe, member of ISO TC 194 and CEN TC 206 and adjunct professor at the University of Milan and Fondazione Alma Mater of Bologna. He is a former Healthcare Engineering HAS consultant for EU Commission.