Built by med-tech professionals
who got tired of
bad tools.
We started Complizen because we’d spent years navigating FDA submissions with tools that weren’t built for the job. Spreadsheets for risk files. Word docs for predicates. Email threads for review. We knew the industry deserved better — so we built it.
“Every medical device team — from a two-person startup to a top-50 OEM — deserves access to the same quality of regulatory intelligence that FDA experts bring to the table. We’re making that true.”
The consultants behind our Services track.
Our Services engagements are staffed by a network of senior FDA consultants — former CDRH reviewers, RA directors, and regulatory affairs Ph.D.s with direct 510(k) experience. Every consultant has independently submitted multiple clearances before joining the Complizen network.
See our services →Citations or nothing
Every answer Complizen gives cites its source. Regulatory work that can't be defended isn't regulatory work — it's guessing.
RA is a craft
Regulatory affairs is skilled professional work. Our tools are built to elevate that craft, not replace it. The RA professional stays in control.
Access matters
A startup shouldn't need a $60k consultant to know if their device is Class II. Complizen levels the playing field — without dumbing it down.
The library stays free
Complizen Learn is free forever. The more the industry understands FDA, the better everyone does. That's not a marketing strategy — it's a belief.
Complizen is a product of Zen Labs Inc., incorporated in Florida. We’re headquartered in Miami and have team members across the US and EU.
We’re a small team building something genuinely important for patient safety. If you’re a regulatory professional, ML engineer, or product designer who cares about medtech — we want to hear from you.
See open roles →For press inquiries, partnership discussions, or speaking requests — reach us directly.