Know your classification
in minutes.
Before you can do anything else in regulatory, you need to know your device classification. Complizen learns about your device, then maps out everything you need next — class, product code, special controls, applicable FDA guidance — so you start with clarity, not guesswork.
More than a class number. The foundation of your regulatory strategy.
Find the right class and code, fast.
Complizen learns your device, queries the FDA classification database, and matches against cleared devices — returning your Class (I, II, or III) and product code, defensible from the start.
Every applicable rule, with citations.
Once your product code is identified, Complizen surfaces every applicable special control with 21 CFR citations — and pulls the relevant FDA guidance documents for your device type.
Know your path before you commit.
Traditional 510(k), De Novo, PMA, or Exempt — Complizen identifies the applicable submission pathway and the current FDA user fee, so pathway decisions are made with full context.
A document you can share, not just an answer.
Every classification comes with a cited rationale document — formatted for your quality system, your investor deck, or your Q-Sub package. Defensible to FDA, internal QA, and stakeholders.
Classification is just the beginning.
Once Complizen knows your device, the same context powers predicate research, Q-Sub strategy, submission building, and risk analysis — for one device, or every device in your pipeline.
“We had our classification and regulatory pathway mapped within hours of getting started. Work that used to feel like the hardest part of the whole process suddenly wasn't.”
