How it works
From a short call to a document you can check line by line
Each engagement sets your device beside the public record of every comparable cleared device. The record does the reading; the consultant does the judging; you receive a sourced document and decide what to do with it.
The engagement
Six steps, the same for every engagement
- 1
A twenty-minute call
What the device does, where you are on the path, and the date you are working to. The call ends with the engagement that fits.
- 2
A fixed scope and fee
A one-page engagement letter: what you send, what you receive, the date, the fee. The first S1 pathway brief is free.
- 3
A signed agreement, then documents
Nothing confidential moves before the confidentiality agreement is signed. It sets the delete-by date, and whether passages may go to a model provider.
- 4
The work
The consultant runs the workspace on the public record and your documents. Every statement is footnoted; every drafted sentence is read and accepted by a person.
- 5
Delivery and a walkthrough
PDF and Word, with an appendix of anything that could not be sourced. A short call walks through it and what comes next.
- 6
Deletion
On the date you set, your documents and the engagement project are deleted from the consultant's machine.
Behind every engagement
The workspace the consultant runs
Twelve steps. At most of them the workspace fills the page from the public record or from your documents, and the consultant decides. The last column shows which engagements use each step: an S1 brief uses six, a submission uses all but the pathway brief.
| Step | The consultant | The workspace | Used in |
|---|---|---|---|
| 1 Open the engagement from the record | Opens a project for the engagement and records the client, the signed agreement and the delete-by date. | Finds the product code from the indications sentence: the codes whose cleared devices say what the device says, each with its regulation name and the three closest statements, quoted. | S1 S2 S3 S4 |
| 2 Device profile model, checked | Reads the client's description and documents; accepts, edits or rejects each proposed field. | Proposes the fourteen profile fields, each resting on the passage it came from, with a flag on any figure the passage does not state. | S1 S2 S3 S4 |
| 3 Pathway brief record + consultant | Records the codes considered and writes a reading of six pathway questions. | Captures the code's record, dated: predicate candidates by later citations, what its summaries state on each element, and up to three precedent passages per element with pages. | S1 S2 S3 |
| 4 Predicate from the record | Chooses the predicate to read, or the reference devices for a De Novo request. | Lists every cited device in the code with how often it is cited, what its summary reports, where its evidence sits, and how close its indications statement is - quoted, with the page. | S1 S2 S3 S4 |
| 5 Base rates from the record | Reads them into the deliverable as the code's record, never as a forecast. | Fetches what summaries in the code state: how many report each element, review times, recalls, change-control plans, with the capture date. | S1 S2 S3 S4 |
| 6 Evidence from the record | For a plan, enters the client's intended approach; for reports, confirms or refuses each proposed passage. | Runs the corpus's own reading rules over the client's documents and proposes the passage for each of thirteen elements, or says it found none. | S2 S3 S4 |
| 7 Equivalence table record + consultant | Confirms the rows, quotes the predicate where the corpus did not read a row, marks the rows that differ. | Fills the subject column from the profile, cited, and the predicate's column where the corpus read the summary, with the page. | S4 |
| 8 Draft model, checked | Accepts, edits or rejects every sentence. | Drafts each section from the profile, passages and predicate cells only; every sentence names its sources, and an unsourced sentence cannot export. | S4 |
| 9 Change control plan record + consultant | Takes the client's answers to eight questions. | Puts the code's precedent language beside each, and drafts the plan from the answers. | S4 |
| 10 Human factors record + consultant | Records the users, environments and tasks the client names. | Maps each task to the guidance's considerations and flags the critical ones. | S4 |
| 11 Acceptance checklist record + consultant | Decides 38 items and says where each is met. | Proposes a state for every item the project can answer. | S4 |
| 12 Export from the record | Reads the whole document, then delivers it with the appendix of what was withheld. | Builds the DOCX and PDF for the engagement, with a footnote on every statement, a cover naming the client and the terms, and an appendix of what could not be sourced. | S1 S2 S3 S4 |
Your documents
Where things live
Your documents are held on the consultant's machine under the signed agreement and read in the workspace there. They are never uploaded to a server, and they are deleted by the date you set.
What it reads
Device Evidence holds the FDA’s list of AI-enabled devices, every clearance document behind it, and a reading of each summary: thirteen elements of validation evidence, each with the sentence and page it was found on, the predicate each device declared, and the chain of predicates behind that. Every figure in a deliverable carries its K-number and page.
What each engagement produces
- S1 Regulatory pathway brief — the product codes considered, and why each was or was not chosen, and more.
- S2 Evidence plan — thirteen evidence elements — sample size, cohort demographics, design, sensitivity, specificity, AUC, reference standard, comparator, sites, prospective collection, outcomes, and more.
- S3 Validation gap review — each of the thirteen elements marked: found (with your document and page), not found, or needs a person to judge, and more.
- S4 Submission drafting — the substantial-equivalence table, the predicate's column quoted from its public summary with pages (or reference devices for a De Novo), and more.
What it never says
Anything about the FDA’s decision on a device, or whether a submission is complete. Precedium prepares content; your regulatory lead reviews it and your signatory submits. A sentence without a source is listed in an appendix, never included.
Start with a free pathway brief
The first S1 brief for your device is free. A twenty-minute call is enough to start: what the device does, where you are, and the date you are working to.