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MedTech news roundup January 2025
Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement…
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Technical Documentation Whitepaper Series | Part 2
In Part 1 of our two-part whitepaper series on technical documentation: Technical Documentation Essentials we covered an outline of what…
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Technical Documentation Whitepaper Series | Part 1
Technical documentation (TD) is key to ensuring medical device safety, efficacy, and quality. As the cornerstone of regulatory compliance, it…
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Congenius Wrapped | 2024
It’s often said that the number 8 symbolises a continuous journey and enduring connection. As we navigated 2024, 8 years…
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MedTech news roundup November 2024
Our MedTech news for November 2024 covers MedTech Europe’s recommendations for EU Green Deal implementation, MDCG guidance on the regulatory…
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MedTech news roundup October 2024
Our MedTech news for October 2024 covers the EU Parliament resolution on MDR revision, MDCG guidance on IVD qualification and…
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PFAS in medical devices
Per- and polyfluoroalkyl substances (PFAS) are set to be increasingly regulated in the EU. In our 5-minute guide below, our…
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Artificial intelligence, machine learning & medical devices | 5 ways to mitigate knowledge gaps
Medical devices containing artificial intelligence (AI) or machine learning (ML) still pose significant challenges for regulatory authorities and manufacturers alike,…
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