Registration & Continental Breakfast

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FDA's New QMSR Is on the Horizon—Will Your Company Be Ready?

On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.” Considering 21 CFR 820 has been the agency’s standard for multiple decades, what is the impact of this alignment with ISO 13485:2016 and how will FDA implement and enforce compliance? The drop-dead date for compliance has been slated for February 2, 2026; and medtech companies (globally) will be expected to comply with the changes. This presentation will dive into: (a) the nuances of the FDA’s changes; (b) edits made to 21 CFR, Part 4 (clarification for combination products); (c) FDA’s development of a new inspection process that better aligns with ISO 13485 requirements; (d) requirements/expectations for compliance; and (e) future changes made to ISO 13485.

Scientific AI for the Medical Device Industry

AI is transforming every industry—and the medical device sector is no exception. NobleAI’s Science-Based AI platform offers a unique, scientifically grounded approach to Practical AI that may align well with the evolving needs of medtech companies. This session features an open conversation between NobleAI and Paul Orlando, an industry leader with deep experience across OEM operations, engineering, procurement, and partnerships with CMs and CDMs. Together, they will define what Science-Based AI is and discuss how medical device organizations can harness it to deliver greater value to customers and patients, while building a sustainable competitive advantage.