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As experienced clinical evaluation writers, we see patterns that repeatedly trigger questions from reviewers. Read more for examples!
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As experienced clinical evaluation writers, we see patterns that repeatedly trigger questions from reviewers. Read more for examples!
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The European Commission recently published a proposal that could be highly relevant for MedTech startups.
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Discover different EUDAMED pathways for submitting device and UDI data and reach the optimal balance between feasibility and efficieny.
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Since ChatGPT’s debut in November 2022, large language models (LLMs) have demonstrated enormous transformative power in various industries, including healthcare and medical devices.
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Join industry leaders, regulatory professionals and Qserve Expert Gert Bos at MedCon 2026 in Columbus, Ohio on Apil 22-24.
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Join Oliver Schaer and Bingshuo Li on 21-23 April at DMEA 2026 in Berlin and explore practical insights on Digital Health.
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The transition to IVDR is entering its final phase, and the clock is ticking for Class C IVD manufacturers, as Notified Body assessment is now required.
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Turning clinical data into a convincing benefit-risk narrative is the ultimate exercise in storytelling. It must be written with the Notified Body’s reviewers in mind.