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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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This blog explores the key regulatory challenges and practical considerations involved in developing companion diagnostics for clinical trials in the US and EU.
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Class B and Class A-sterile IVDs now need notified body sign-off. Get the 8-step plan to apply before May 26, 2027, and what the IVDR 2.0 proposal could change.
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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.