No-fluff writing for product teams building in regulated industries.
An honest breakdown of which requirements tool actually works for regulated startups in 2026 — and why every option has a fatal flaw until you look past the enterprise defaults.
MCP lets you connect your own LLM directly to your requirements tool — and for regulated teams, that's not just a feature, it's the only responsible way to bring AI into compliance workflows.
A practical guide to what a complete traceability matrix actually looks like for ISO 13485 and IEC 62304 — and the specific mistakes that turn auditors into adversaries.