Services
Four engagements, each a document you can check line by line
Fixed in scope and quoted per engagement after a short call. The first S1 pathway brief for your device is free.
- S1
Idea / early design
Regulatory pathway brief
Where does our device fit, and what has the FDA already cleared that looks like it?
- S2
Planning validation
Evidence plan
What will our validation have to show, and what should we ask the FDA before we run it?
- S3
Validation done
Validation gap review
Do our reports state what cleared devices in our code stated, and where are the gaps?
- S4
Ready to file
Submission drafting
Can the submission content be assembled without losing three weeks to tables and checklists?
| Engagement | Your stage | You send | You receive |
|---|---|---|---|
| S1 · Regulatory pathway brief About a week from the call | Idea to early design: the device exists on paper or as a prototype | A one-page description of the device; Its intended use and indications, in a sentence or two; Anything you already know about similar devices | The product codes considered, and why each was or was not chosen; The predicate candidates in your code, ordered by how often later clearances cite them, with each one's lineage; The code's record: how many devices cleared, what their summaries state, how long past reviews took, and recalls with their root causes; and more on the engagement page |
| S2 · Evidence plan One to two weeks from receiving the plan | Development: you are planning the validation study or a Pre-Submission | Your intended use; Your draft validation plan or protocol outline; The product code, if known (S1 settles it if not) | Thirteen evidence elements — sample size, cohort demographics, design, sensitivity, specificity, AUC, reference standard, comparator, sites, prospective collection, outcomes; For each: how often cleared summaries in your code state it, and up to three passages where they did, with the K-number and page; Your plan beside the precedent, in your words; and more on the engagement page |
| S3 · Validation gap review Within a week of receiving the reports | Validation done: the reports are written and a filing date is set | Your validation and performance test reports; The device description and product code | Each of the thirteen elements marked: found (with your document and page), not found, or needs a person to judge; The gaps ordered by how often cleared summaries in your code state each element; Each gap phrased as a question to answer before filing; and more on the engagement page |
| S4 · Submission drafting One to three weeks, depending on the document set | Ready to file: the documents exist and the content needs assembling | The full document set: test reports, device description, labeling, software documentation; The predicate, if chosen | The substantial-equivalence table, the predicate's column quoted from its public summary with pages (or reference devices for a De Novo); Drafted sections in which every sentence cites your document or a predicate page, reviewed sentence by sentence; The FDA's acceptance checklist, item by item, mapped to where each is met; and more on the engagement page |
Priced per engagement
A fixed fee agreed before work starts. No subscription and no software to buy.
Confidential by contract
Documents arrive under a signed agreement, stay on the consultant's machine and are deleted by the date you set.
Sourced, or not included
Every statement carries a footnote. A sentence without a source is listed in an appendix, never slipped into the text.
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.