Standards for reprocessing have become a top priority for regulatory bodies worldwide. The active work around reusable medical devices has challenged the medical device industry to rethink their traditional approaches. Updates in Medical Device Regulation (MDR), the International Organization for Standardization (ISO), and the Association for the Advancement of Medical Instrumentation (AAMI) have collectively driven significant advancements in this area, bringing renewed attention to the predicate devices used for market approval submissions of reusable products.
Technological innovations and the advancement of design and functional features of medical devices have raised questions about the validity of existing design history files (DHF). This presentation will delve into the critical aspects that medical device manufacturers need to evaluate in their design history files or device portfolios to ensure compliance with current standards and expectations for reusable medical devices.
The webinar will provide a comprehensive overview of the necessary evaluations and updates that manufacturers must consider to align with the latest regulatory requirements. Participants will learn about the impact of technological advancements on device design and the importance of maintaining up-to-date and accurate design history files.
Additionally, the presentation will address the current trend of shifting from single-use devices to reusable ones, highlighting the challenges and opportunities this transition presents. The session will explore the specific challenges associated with reprocessing 3D-printed devices, which bring unique complexities to the reprocessing landscape.
By understanding these critical factors, medical device manufacturers can better navigate the evolving regulatory environment and ensure that their products meet the highest standards of safety and efficacy. This presentation is essential for professionals involved in regulatory affairs, quality assurance, product development, and manufacturing within the medical device industry.
Join us to gain valuable insights into the latest standards for reprocessing reusable medical devices and learn how to effectively evaluate and update your design history files to comply with current regulatory expectations.