Cruxi on Product Hunt

We just launched Cruxi on Product Hunt – an AI copilot for FDA 510(k) submissions. For most early-stage medtech teams, the real pain doesn’t start with code or hardware… it starts when someone says: “Okay, now we need to figure out the 510(k).” Suddenly you’re dealing with: product codes and classifications picking a credible predicate digging through guidance documents understanding testing expectations formatting everything into eSTAR It’s slow, expensive, and intimidating – especially if you don’t have a big RA/QA team or a six-figure consulting budget. With Cruxi, we’re trying to make this part a lot less chaotic: Map your device to the right regulation and product code Surface relevant predicates, guidance, recalls, and safety intel Outline likely testing and documentation expectations Generate eSTAR-ready draft content you can review with your RA/QA team or consultant Cruxi is not meant to replace experienced regulatory professionals. It’s a focused copilot to help teams avoid blind spots, ask better questions, and move faster with more confidence. It’s also a very niche product. If you’re not in medtech or regulatory, this may sound like a different universe – and that’s okay 🙂 🔗 We’re live on Product Hunt today: https://www.producthunt.com/products/cruxi?comment=5030895 If you work in medtech, digital health, RA/QA, or consulting, I’d really appreciate: your honest feedback, a comment on how you currently handle 510(k)s, or thoughts on where an AI copilot like this would (or wouldn’t) fit into your workflow. Thanks in advance to anyone who takes a look or shares it with someone in their network who battles FDA 510(k) submissions for a living.