As of January 2024, AI could handle approximately 40-60% of the regulatory processes in the Medtech Industry, including tasks such as data analysis, monitoring regulatory updates, and standardizing documentation. However, with recent advancements and the expanding capabilities of AI, its impact on the regulatory affairs professional may exceed these projections. This forum discusses and strategizes on integrating AI in regulatory affairs for medical devices and IVD products, spanning the entire product lifecycle. We focus on exploring AI’s potential to exceed expectations in enhancing and streamlining these processes.

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