In 2018, TC194, the ISO committee responsible for biocompatibility, released a new version of the 10993-1 standard. This updated version introduced a more robust risk-based approach and incorporated significant changes aimed at improving the safety and effectiveness of medical devices. As the industry adapts to these changes, further significant revisions are being made to the main biocompatibility standard.
This presentation will explore the latest updates to ISO 10993-1, highlighting the areas of the standard that are undergoing changes. We will delve into the rationale behind these revisions, providing insights into why these updates are necessary and how they enhance the biocompatibility evaluation process. The discussion will cover key aspects such as the introduction of new testing methodologies, enhanced risk assessment protocols, and improved guidance on material selection and characterization.
Additionally, the talk will address the initial acceptance and implementation of these changes across the globe. We will examine how different regions are responding to the updated standard and the challenges and opportunities that arise from its adoption. Understanding the global perspective is crucial for manufacturers seeking to ensure compliance and maintain market access for their products.
By attending this presentation, professionals involved in the design, development, and regulatory compliance of medical devices will gain a comprehensive understanding of the evolving biocompatibility standards. This knowledge will help them navigate the regulatory landscape, implement the necessary changes in their processes, and ensure their products meet the highest standards of safety and efficacy.
Join us to stay informed about the latest developments in ISO 10993-1 and learn how these changes can impact your organization and the broader medical device industry.