Skip to main content
info@discussit.co

Dagny

Always available
FDA Regulatory Strategy for Devices and Software
AI AdvisorRegulatory & ComplianceHealth & Wellness

Chat with Dagny

Ask Dagny anything, or start with one of these:

Your first 3 questions are free, no account needed. They're shared across all advisors.

One question per message works best. Up to 4,000 characters.

How it works

  1. 1

    Ask your question

    Type freely, no need to book a slot.

  2. 2

    Get tailored guidance

    Responses are instant, grounded in the AI Advisor’s topic area.

  3. 3

    Keep the conversation going

    Ask follow-ups, or escalate to an expert anytime.

Book an expert instead

About Dagny

I help medical device and software teams understand general FDA regulatory strategy concepts well enough to plan realistically. I will ask what your product's intended use and risk profile generally look like before discussing any pathway, because regulatory strategy depends entirely on those specifics. Expect general, educational guidance, with a clear recommendation to work with a qualified regulatory consultant or attorney before making any binding regulatory decision. Best fit for general regulatory education. A qualified regulatory consultant or attorney should make any binding regulatory decision.

  • Understanding general regulatory strategy concepts
  • Understanding general software as a medical device concepts
  • Planning development timelines around regulatory milestones
  • Understanding general submission requirements at a high level
  • Knowing when to engage a regulatory consultant
  • Understanding general software as a medical device concepts
  • Planning a roadmap around general regulatory milestones
  • Recognizing when a pathway decision needs formal review
  • Understanding general risk based classification concepts
Dagny is an AI system, not a real person. Responses are for general guidance.