Any regulatory document,
drafted for you.
Device descriptions, test protocols, Q-Sub requests, submission sections — anything that needs regulatory knowledge and your device data pulled together. Complizen has both, so it writes the first draft in seconds, with the right citations and structured the way the FDA expects. You review and refine instead of starting from a blank page.
Your document. Your starting point.
Pick a template
Choose from Complizen’s library of submission-tested templates. Every template is structured for eSTAR and annotated with what FDA expects in each section.
Upload your own doc
Already have a draft? Upload it. Complizen reads the structure, maps it to the correct submission sections, identifies gaps, and suggests what needs to be added — without overwriting your work.
Start from scratch
Describe your device and the document you need. Complizen generates the first draft from your device profile — section structure, language, citations, and all.
You write. AI catches what you miss.
A rich-text editor where every paragraph can be rewritten, tightened, or expanded by AI on demand — or left exactly as you wrote it. Your document, your control.
- Inline “Ask AI” — rewrite, tighten, or expand any selection
- Citations auto-linked as you type — every claim traced to its source
- Section compliance hints — green when FDA-ready, flagged when not
- Version history per paragraph — nothing is ever truly deleted
The subject device’s catheter shaft uses a polyurethane construction with a working length of 110 cm, identical to the predicate K211045. Performance testing demonstrated equivalent tensile strength, kink resistance, and torque response across all benchtop conditions. Biocompatibility evaluation followed ISO 10993-1 with no new risks identified versus the predicate.