Mental health products often start with a simple idea. A team wants to help people track their mood, understand stress, build healthier habits, or access structured self-help content. At that stage, the product may look like a wellness app. But the regulatory question changes when the product starts to assess symptoms, guide decisions, recommend interventions, […]
Large Language Models are changing how MedTech teams work, and one of the most practical areas of impact is SaMD regulatory documentation. For companies developing Software as a Medical Device, documentation is not just an administrative task. It is a core part of the product’s compliance story, the evidence trail behind key decisions, and often […]
The EU MDR 2026 amendments are the most consequential shift in European medical device regulation since the original EU MDR 2017/745 entered application. For global Pharma and MedTech organizations developing Software as a Medical Device (SaMD) and Digital Therapeutics (DTx), these amendments do not simply update compliance requirements; they fundamentally changed product strategy, investment priorities, and speed […]
