12 months. Still not filed.
Hourly billing = slow work
Fixed price · 7× faster delivery
Medical device regulatory consulting
Medical device consulting. Cleared faster.
FDA Experts + AI. Fixed price. 7× faster than traditional firms.
5.0 / 5.0Google
- FDA Expert on your file.
- Fixed price. No hourly billing.
- AI drafts. Experts sign off.
- 7× fastervs traditional consulting
- 200+medtech teams served
- Fixed pricebefore we start
Request Consultation
Tell us your device. Pathway + fixed price within 1 business day.
Trusted by medical device teams worldwide
Sound familiar?
Hourly billing kills momentum.
Traditional firms sell time. We sell clearance.
Senior at kickoff. Junior does the work.
Partner sells. Juniors draft.
FDA Expert reviews every page
Research eats the budget.
Manual FDA research burns budget
AI researches. Experts validate.
“Fraction of the time. More clients. That’s Complizen.”
Melissa HallFounder & Principal Consultant, Statera Consulting
Consulting services
What we do
One team. One price. FDA-ready.
510(k) submissions
Predicate to eSTAR. Expert-reviewed. FDA-ready.
Regulatory Strategy
Pathway mapped before you spend.
Predicate & classification
AI research. Expert citations.
Gap analysis
Know what's missing. Fix it early.
FDA responses
Deficiency letters. FDA Expert backup.
About us
FDA experts. AI builders.
Complizen is built by FDA regulatory experts and the engineers behind the AI that powers them — 30+ years of combined experience taking medical devices through the FDA and building the technology that gets you there faster. Strategy, predicates, and submissions, run by people who’ve filed before and sharpened by AI systems we build in-house.
- 30+ years combined FDA regulatory experience
- AI systems built in-house, not bolted on
- An FDA Expert on every file
Who we work with
Built for device teams
Startups
First 510(k)? Senior RA lead. No full department needed.
OEMs
Next device cleared faster. Fixed price beats hourly.
Growth-stage
Expanding your pipeline? One team for every FDA pathway.
Request Consultation
Tell us your device. Pathway + fixed price within 1 business day.
Proof
200+ medtech teams trust us
7× fastervs traditional firms
200+medtech teams
FDA Experton every file
Trusted by medical device teams worldwide
SOC 2 alignedAES-256 encryptedYour data never trains AI
FAQ
Quick answers
Is this just another medical device consulting firm?
No. Firms bill hours. We pair FDA Experts with AI — AI drafts, experts review. Faster. Fixed price.
What consulting services do you offer?
510(k), De Novo, PMA strategy, predicate research, gap analysis, FDA responses. Scoped to your device.
How does pricing work?
One fixed price before kickoff. No hourly billing. Milestone payments. We win when you're cleared.
How long does a typical engagement take?
7× faster than traditional consulting — submission-ready in months, not a year. Cleaner files mean fewer FDA deficiencies.
When should we engage you?
Early — before predicate or testing is locked. We also join mid-project and for FDA deficiency responses.
What companies do you work with?
Startups to OEMs. If there's a viable pathway, we map it and execute.
Schedule
Request your consultation
30 min with an FDA Expert. Pathway + fixed price. Free.