Join us for an engaging podcast featuring business leaders from Nelson Labs who have just returned from the 2023 AAMI Biological Evaluation Standards week meetings. In this episode, experts Thor Rollins, Audrey Turley, Chad Summers, Russell Sloboda, and Raymond Colton share their key learnings and insights from working group discussions and updates to the various ISO 10993 standards.
Thor Rollins will discuss significant developments in biocompatibility testing, focusing on new methodologies and regulatory expectations that are shaping the industry. Audrey Turley will provide an overview of the latest updates to ISO 10993-1, emphasizing the importance of a risk-based approach to biological evaluation and the ongoing efforts to reduce animal testing.
Chad Summers will delve into the revisions of ISO 10993-18, highlighting changes in chemical characterization of medical device materials. He will explain how these updates impact the evaluation of potential risks associated with leachables and extractables.
Russell Sloboda will cover the updates to ISO 10993-17, which focuses on establishing allowable limits for leachables. His insights will help listeners understand the implications of these changes for ensuring patient safety and compliance with regulatory standards.
Raymond Colton will round out the discussion by addressing updates to ISO 10993-23, which deals with in vitro tests for skin irritation. He will share the latest advancements in alternative testing methods that are helping to minimize the reliance on animal testing.
This podcast is a must-listen for professionals involved in regulatory affairs, quality assurance, product development, and testing within the medical device industry. Gain valuable insights from industry experts and stay informed about the latest developments in biological evaluation standards. Tune in to ensure your organization remains compliant and ahead of the curve in this rapidly evolving field.