ISO 10993-18 was released in 2020 and specifies how to identify and quantify the constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents. When it comes to extract medical devices this Standard provides useful guidelines on the solvent, methods and conditions to be used. But how to approach substance-based and drug-like medical devices?
This webinar will show the critical aspects of determining the appropriate strategy for chemical characterization of substance-based and drug-like medical devices. Practical example will be presented providing insights into the techniques recommended for conducting Extractables and Leachables testing in this specific context.
Chemical characterization: how to perform an E&L study for drug-like medical devices?
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: February 22, 2024 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://register.gotowebinar.com/register/8736695641662435931
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.
Daniele Lioi is a Senior Consultant and Team Manager of the Eurofins Italian Medical device consultancy team. Since 2017, he has been dealing with Biological Risk assessments, Clinical Evaluation and Supporting the compilation of the technical documentation for medical device manufacturers. He has a biotechnology background with experience in regulatory affairs of medical devices. Daniele recently obtained the qualification as Auditor/Lead Auditor ISO 13485/ISO 9001, he is included in the national registry for person responsible for regulatory compliance and he joined the HAS consultants team for the harmonization of International Standards.
Enrico Franzoni is a chemist, graduated in 1997 at Università degli Studi of Milan, with more than 20 years of experience in the analytical field; after experiences in the environmental and semiconductor fields he has been working in Eurofins Biolab from 2003.
From 2003 to 2013 he was project leader of drug products GMP studies dealing mainly with extractables and leachables and method validations.
He has been Manager of Medical Devices Chemical Characterization Laboratory in Eurofins Biolab Milan since its creation in 2013, during its activity he managed a wide number of activities on all kind of medical devices.