In this webinar, a biological evaluation plan for a combination device will be gradually built while focusing on the chemical characterization to be performed.
First, we will explain the importance of understanding the exact use of the combination device, definition of the parts of the device that can be of biological or chemical concern for a patient, and the need for a detailed material characterization.
Subsequently, we will elaborate on the chemical characterization for this type of device, taking into account the requirement for Carcinogenic, Mutagenic and Reprotoxic Compounds as specified in section 10.4 in Annex I of the MDR. This is especially important for products falling under article 117.
Finally, we will delve into the necessity of drug-device compatibility in the overall biocompatibility evaluation, and why these important aspects should not be forgotten nor neglected.
For more information and to sign up, please visit: https://www.medteclive.com/en/exhibitors-programme