In this comprehensive webinar, we will explore the crucial role of chemical characterization studies (ISO 10993-18) in meeting the stringent requirements of section 10.4 of the Medical Device Regulation (MDR). The presentation will provide a detailed explanation of how these studies can support compliance with MDR mandates, particularly in terms of labeling obligations and risk assessments.
The webinar will start by outlining the key requirements of section 10.4 of the MDR, emphasizing the necessity for thorough chemical characterization of medical devices. Participants will learn how chemical characterization helps identify and quantify chemical constituents in medical devices, which is essential for ensuring patient safety and regulatory compliance.
Understanding the difference between targeted and screening analytical approaches is another core component of this webinar. Participants will gain insights into when and how to use these different approaches, as well as their respective levels of quantification. Targeted analysis focuses on specific known compounds, offering precise quantification, while screening analysis provides a broader overview, identifying potential unknowns that may pose risks.
By the end of this session, participants will have a thorough understanding of how chemical characterization studies can be leveraged to meet the requirements of section 10.4 of the MDR. They will be equipped with practical knowledge and best practices for conducting these studies, ensuring accurate risk assessments and compliance with labeling obligations.