Insights on DHT compliance
EU MDR, FDA DHT guidance, EUDAMED, data integrity and the operational reality of digital health in clinical trials.
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2 articles tagged “Change control”
7 Jul 2026
Not in EUDAMED? If You Import the Device, the Obligations Are Already Yours
Who is the importer of record for the devices in your trial — and does that person know it? If a device on your study isn’t in EUDAMED, can you still legally…
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11 Feb 2025
Navigating AI Regulations: Insights on FDA’s AI/ML Guidance and the EU AI Act
How do the FDA's AI/ML guidance and the EU AI Act differ in regulating AI in life sciences? What challenges do life sciences companies face when complying…
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