Evidence-first writing on EU AI Act compliance, SaMD statistical validation, and industrial AI due diligence. No hype, no generic frameworks — specific questions, specific evidence.
Team-NB published a 189-question checklist for AI in medical devices. Most questions are manageable — but six require evidence that most technical files don't contain today. Here is what they ask for and why it takes time to produce.
Read article →Three out of four AI medical devices on the European market will be treated as high-risk under the EU AI Act. Article 10 requires evidence that most technical files don't contain: representative validation data, documented statistical properties, and bias assessment across subgroups. One accuracy number is not enough.
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