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Know if your device needs a clinical investigation under MDR, and how ISO 14155:2026 shapes the study. Learn the exemptions, pitfalls and next steps.
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Missing the 28 November EUDAMED deadline puts your devices at risk of non-compliance. Learn what’s at stake and how to get your data submitted in time.
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Learn how to structure a PMCF plan under the EU MDR. Walk through sections A to G of MDCG 2020-7 and avoid four common pitfalls before your Notified Body does.
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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.