MAATIQ AGENT WORKBENCH
A review workbench for FDA compliance consultants: AI lays out every finding with its CFR basis and source evidence, and you adjudicate each one from the keyboard. Ten times the review throughput, and the signature is still yours.
Includes a demo review. Try it in 5 minutes.
Click a finding and the left pane highlights the exact label text it cites, while the right pane shows the CFR citation and the AI confidence score. Defensibility is not a slogan: every single finding carries an evidence chain.
J/K to move, A to accept, R to reject, M to modify, N to add a missed finding. A few keystrokes clear a finding, and clearing a whole submission takes minutes.
Co-branded PDF: your firm's name, your signature, and only the items you have adjudicated. Unreviewed AI proposals never appear in front of your client.
DEVICE 510(k)
The same consultant adjudication workbench now supports pre-submission review for FDA 510(k) medical devices.
Create a free accountAutomatic checks across 43 510(k) RTA / eSTAR technical screening items to catch administrative and format gaps before hold.
Checks whether Q-Submission questions are specific and answerable by FDA, with gaps around predicate strategy, clinical evidence, and cybersecurity files.
Cost and speed calibrated from a measured device run: about $0.10 and about 80 seconds for the initial findings.
Upload label photos and OCR fills the form automatically
Multi-layer AI review produces findings, each with severity, CFR citation, and source evidence
You adjudicate line by line and generate a report under your name in one click
Organization-level isolation and a full audit trail (who, when, what changed; exportable).
By design, no finding enters any report without your adjudication.
Every report includes a methodology note and a consolidated index of CFR citations.
まず 30 日間フル機能を試してから、プランを決めてください。
支払い情報の登録なしで、実案件をフル機能で扱えます。
毎週クライアント案件をレビューするコンサルタント向け。
価格はすべて米ドルです。参考:手作業のラベルレビューは通常 1 件 $250 以上です。
DESIGN PARTNER
Three months of full access, free, in exchange for your real usage feedback. Closed once full.