Dialog: MDR/AI - Understand your regulatory position under EU MDR and AI Act.

I built the tool I wish existed when I was classifying borderline medical devices. Over the past 20 years I've been on every side of the EU MDR classification table - in various C-level roles, as regulatory lead and as the person explaining to investors why their portfolio company is (or isn't) a medical device. One pattern keeps repeating: Teams assume they're a medical device because someone told them to "err on the side of caution." That sounds prudent. In practice, it means: - EUR 200K+ in unnecessary NB engagement - 12-18 months of velocity lost - Engineering decisions shaped by a classification that was never properly challenged The opposite is just as dangerous - teams that assume they're NOT a device because their product "only provides information." Both fail for the same reason: no structured analysis of where the borderline actually sits. MDCG 2019-11 is clear about how to assess this. So is the EU AI Act via Article 6(1). But most teams never see a structured analysis that uses these properly - just a confident opinion and a big invoice. So I built DLG: MDR (Dialogue). DLG produces a structured regulatory assessment covering: - MDR classification with visible reasoning - EU AI Act risk tier and the dual-framework interaction - A borderline assessment when the case is contested - What must remain true for the current position to hold - Practical next steps calibrated to your stage Every report is reviewed by me personally and delivered within 1 business day.