Resources · Regulatory Pulse
Regulatory Pulse
Quarterly notes on the regulation that actually moves DCT and RPM forward — ICH E6(R3), FDA decentralized guidance, EU MDR, and the practical impact on study design.
Inaugural issue · in preparation
Inaugural issue — coming in 2026 Q3
The first edition of the Vitruvian Shield Regulatory Pulse will cover the ICH E6(R3) transition, FDA decentralized trial guidance, EU MDR clarifications for software-as-a-medical-device, and the practical impact on academic and mid-market study designs. Subscribe to receive it as soon as it goes out.
ICH E6(R3)FDA DCTEU MDRSaMD
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