WHY SHOULD I JOIN THE WEBINAR?
The new version of ISO 10993-18 Chemical Characterization of Medical Devices has been published in January 13th, 2020. Also the compliance with the new MDR will converge to the approach settled by the new approach of ISO 10993-1:2018 for Biological Evaluation of medical devices.
If compared with the previous edition the new Standard increases the level of integration and harmonization with current versions of ISO 10993-1 and ISO 10993-17. The focus of chemical characterization emphasizes raw materials evaluation also taking into account the presence of any impurities or residues associated with the manufacturing and sterilization process that may impact medical devices biocompatibility.
Chemical characterization becomes a key factor in the assessment of the biological evaluation since obtained data are fundamental to correctly set the biological risk assessment of medical devices and also to plan how to evaluate biological effects relevant to the device.
The new version of ISO 10993-18 specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally step wise approach to the chemical characterization.
This event will provide an up-to-date overview on normative changes of the new ISO 10993-18 in relation with to the biological evaluation of devices and planning for future testing
WHO SHOULD PARTICIPATE?
- Regulatory affairs and QA experts
- Research, design & manufacturing engineers
- Experts involved in the evaluation of Medical Devices
- Product Managers & Laboratory Managers
- Process development & system engineers
- Toxicologists & biological safety experts
EVENT KEY NOTE SPEAKER?
Paolo Pescio, ERT
- 15+ years of experience with medical devices
- European Registered Toxicologist (ERT)
- HAS consultant
- Toxicological evaluation and risk assessment
- Biological evaluation of medical devices
- Integrated Testing Strategies
Official Language: English
** Israel Time Zone