01
Upload your device info
Drop in what you have — specs, intended use, test reports, IFU drafts. Any format. Complizen reads it all into a structured device profile.
510(k) Building
FDA 510(k) cleared,
Half the time.
Half the cost.
Complizen combines an ex-FDA regulatory team with our proprietary AI platform to accelerate your 510(k) clearance.
- Fixed fee per engagement
- Senior FDA consultant review
- 94% RTA pass rate
Time to FDA submission
Complizen8–12 weeks
Fixed fee. Senior FDA consultant review. One centralized workspace.
The traditional path6–9 months
Hourly billing. Scattered tools. Open-ended revisions.
94%
RTA pass rate
2×
Faster than traditional
How it works
Five steps from device profile to FDA submission.
One workspace. Your team and ours, end to end.
02
Submission plan, auto-generated
Complizen maps your full submission against the latest eSTAR template. Every section, every dependency. You and your FDA expert in the same workspace from day one.
03
AI drafts every section
Each section drafted from your device profile, predicates, and applicable FDA guidance. Citations under every claim.
04
FDA expert review
An ex-FDA regulatory expert reviews every section as it's drafted. Inline comments, tracked changes, sign-off — fully visible to your team.
05
Compiled and ready to submit
Your eSTAR is compiled into FDA-portal-ready format. You upload. We stay on call through the review period.
Want to talk through your specific device with an expert? We'll walk you through the whole process — no commitment.
Book a 30-min callThe division of work
What you bring. What we build.
What you provide
- Device description and intended use statement
- Predicate preferences (or we choose)
- Test reports and bench data (as available)
- Labeling and IFU drafts (or we draft)
- Biocompatibility data or equivalence rationale
- Software documentation (if applicable)
- Access to manufacturing/sterilization details
What we build
- Full classification, pathway, and predicate strategy
- All 22+ eSTAR sections, AI-drafted with citations
- Predicate comparison table and SE narrative
- Risk analysis seeded from MAUDE history
- Section-by-section expert review and sign-off
- RTA pre-flight check against current FDA criteria
- Complete eSTAR package, portal-ready
- One centralized workspace — every draft, citation, and review thread in one place
Pricing
Fixed fee. No hourly billing. No surprises.
Every engagement includes full AI drafting + senior consultant review. Complexity tiers reflect device type and submission scope — not billable hours.
Step 01
Discovery call + NDA
30 minutes. Tell us about your device. We sign an NDA so you can share specs freely.
Step 02
We scope your submission
Together we determine the tier — Basic, Standard, or Complex — based on device type and submission scope.
Step 03
Fixed quote
One number, in writing. No hourly billing, no surprises, no scope creep through revisions.
The three tiers
Three engagement tiers, all fixed-fee. Where your device lands depends on complexity and scope — we’ll determine it together on the scoping call.
Tier 01
Basic
A straightforward Class II 510(k) — clear predicates, standard testing, established product code.
- Class II device with clear predicates
- Standard testing (bench, biocompat, sterility)
- Established product code
Tier 02
Standard
Devices with novel features, multiple viable predicates, or more complex testing requirements.
- Novel features or multiple predicates
- Complex testing (EMC, combination, sterility validation)
- Q-Sub strategy commonly recommended
Tier 03
Complex
SaMD, significant software components, novel pathways, or devices with substantial cybersecurity scope.
- SaMD or significant software components
- Cybersecurity & IEC 62304 documentation
- Novel or first-of-kind features
Get your fixed quote30-minute call. NDA on request. No commitment to start.
Add-on services
Beyond the submission, we can also handle…
The pieces around a 510(k) that most teams need at some point. Bundle any of these into your engagement — we’ll quote them on the same scoping call.
US Agent
Required for non-US companies. We act as your designated US Agent for FDA correspondence — fast turnaround, no friction.
Small Business Designation
Apply for SBD status to reduce FDA user fees by up to 75%. We prepare the application and manage the SBD process end-to-end.
Facility Registration
Annual FDA establishment registration and device listing — we handle the filings and renewals so you stay compliant.
Frequently asked questions
Who is this for?
Any medical device company preparing a 510(k) submission — whether it's your first, you don't have an RA team, or you want to move faster than traditional consulting allows.
We have an internal RA team. Can we still use Complizen?
Absolutely. If you have an internal RA team, the Submission Builder platform is the better fit — your team drives the AI drafting and runs review and approvals in-house. This service is for teams who want senior consultant review included; the platform is for teams who want to keep review on their side.
Can I use my own consultant?
Yes. Use Submission Builder directly — you drive the AI drafting, and you can invite your own consultant into the workspace to review and sign off. Same drafting power, your reviewer.
I'm a consultant. Can I use Complizen for my clients?
Absolutely. Many of our current users are independent consultants and RA firms using Submission Builder to help their clients get to market faster. The AI does the drafting heavy-lift; you bring the expertise and the relationship. See the Submission Builder platform for how it works.
Do I need to have all my test data before starting?
No. We scope the submission first, then map what testing you still need. We can help you select labs, write test protocols, and integrate results as they arrive — without holding up the sections that don't depend on test data.
What if we need a Q-Sub meeting first?
We'll recommend a Q-Sub if your device is novel or the pathway is genuinely unclear. Q-Sub prep and meeting management can be included in your engagement scope — we'll discuss it on the scoping call.
How does the expert review actually work?
Your consultant has a dedicated view in the Complizen workspace. They review sections as they're completed, leave inline comments and tracked changes, and flag items that need your input. You see every comment, approve every change, and sign off before anything goes to FDA.
Who are your FDA consultants?
Former CDRH reviewers, RA professionals with 10–25 years of direct 510(k) experience, and regulatory affairs PhDs. All consultants have submitted multiple 510(k)s independently before joining the Complizen network. We'll introduce you to yours before kickoff.