Regulatory & Quality
The precedent behind the guidance.
Answers from real FDA decisions
Questions are answered from a curated library of FDA guidance and published regulatory decisions, never from customer submissions. The answer reflects what reviewers actually did, rather than what the guidance leaves open to interpretation.
Every answer carries its evidence
Each response quotes the passages it relied on and names the document each one came from, so you can judge the reasoning yourself instead of trusting a summary.
It tells you when it doesn't know
The model may only use the documents it retrieved, never outside knowledge. When the library has nothing that bears on your question, the answer says so instead of filling the gap with something plausible.
Post-market · MedISAO
Regulatory Intel covers what FDA has decided. For what attackers are actually doing, there's MedISAO. It shares weekly vulnerability advisories, runs a turnkey coordinated disclosure program across the device industry, and is Medcrypt's FDA-recognized ISAO, operating under a CDRH Memorandum of Understanding since 2018. Membership starts at $1,200 per year.