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Navigate AI-enabled medical device registration across Asia-Pacific. Discover key regulatory considerations, market strategies, and local requirements.
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EN 18286 is here. See how it differs from ISO 13485, what is really new, and where to start updating your QMS for the AI Act.
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ISO 18969 has reached FDIS. See where the clinical evaluation standard stands, what it changes for manufacturers, and how to prepare before publication.
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Join Qserve's Gert Bos and Bianca Lutters at the MDR Symposium on October 28 to make sense of the MDR transition together with industry experts.
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Join Gert Bos at the Global Access 2026 in Galway to discuss international regulatory trends and connect with other QA/RA professionals.
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Join the DIA Medical Devices and Drug-Device Combination Products Workshop: Post-Market Surveillance and Clinical Evidence with Bianca Lutters.