Two sessions in the Tech Theater at MD&M Minneapolis will focus on regulations and standards that affect medical device development. In the first presentation, “US FDA Adoption of the Quality Management System Regulation — How Should You Prepare,” Tim Gooch, BSEE, technical director, Life Sciences Management Systems and Supply Chain at SGS North America, will explore how the purpose of the proposed change is to better align the agency’s medical device quality management system requirements with the international consensus standard for devices, ISO 13485: 2016 (the standard), used by other regulatory authorities. In 2022, the United States Food and Drug Administration proposed an amendment to 21 CFR 4 and 820.
He will discuss how this will affect quality management system (QMS) requirements for both medical devices and combination products involving both medical devices and drugs. This presentation will include information directly from key individual within the agency on what expectations will be for current activities for the greatest impact toward compliance with the new requirements. Tuesday, October 10, 11:00–11:45 AM Central Time.
In the second presentation, “The Impacts of Updated Standards on IFU Validations for Reusable Medical Devices,” Alpa Patel, director of scientific improvement at Nelson Laboratories, will address how advancements have resulted in numerous standards and guidance documents being either updated or created to ensure that reusable medical devices can be safely reprocessed. As reusable medical devices continue to advance, the validations used to evaluate the reprocessing (cleaning, disinfection, and/or sterilization) procedures have had to advance as well. This presentation will discuss these changes as found in documents such as AAMI ST98, AAMI TIR12, ISO 17664, as well as others. Additionally, this presentation will discuss how these changes impact new and already completed reprocessing validations for reusable medical devices and what is next for these validations. Tuesday, October 10, 1:00–1:45 PM Central Time.
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