EU Green Deal & Directives 2025
The European Green Deal, adopted in December 2019, is the European Union’s ambitious roadmap to transform Europe into the first…
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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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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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Clinical evaluation under MDR | Determining adequate clinical evidence
The introduction of MDR has significantly increased the importance of clinical evaluation for medical devices. And whilst several guidelines exist…
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How the AI Act, NIS 2, & Data Act will impact the EU medical devices regulatory landscape
Between August this year and September next year the regulatory environment in the EU regarding data will become more complex,…
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Design Control for Software | An introduction
The number of regulations, standards, and guidance documents specific to software in or as a medical device (SiMD, SaMD) is…
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