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: October 26, 2023 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://register.gotowebinar.com/register/5621819879360120671
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
The risks of long term systemic effects according to ISO 10993-11 and local effects after implantation according to ISO 10993-6 should be addressed for all implantable medical devices. In order to reduce the number of animals used, for a more ethical use of animals according to the three Rs, it is possible to combine these evaluations. Nevertheless, when conducting combined studies for evaluating local effects and systemic effects, one should pay attention to fulfill the requirements of both standards.
The webinar aims to provide an overview of the regulatory requirements related to those evaluations and give inputs for the pre-clinical study designs through the use of case studies.
