Collect
Store records and their source identifiers.
SKOLVO / SIGNALWATCHVALIDATION BUILD · NOT PRODUCTION MONITORING
REGULATORY INTELLIGENCE / 01
The FDA record,made reviewable.
SignalWatch is a working validation build for independent medical-device consultants. It turns public FDA records into source-linked alerts and reviewable briefs across separate client workspaces.
TRACE / ILLUSTRATIVEFACT BOUNDARY ON
510(k)RECALLPMA
SOURCE FOUND SCOPE MATCH HUMAN REVIEW
SignalWatch / COMMERCIAL SUMMARY
What customers receive.
For: Independent medical-device regulatory consultants reviewing public FDA activity across clients.
Problem: Manual source checking is repetitive, while each client still needs a separate, reviewable evidence trail.
CORE DELIVERY
- Client-specific watch configurations
- Matched 510(k), MAUDE, or Enforcement record review
- Source-linked intelligence reports for professional review
- FREE USE
- 1 sample historical intelligence report per service — no card required.
- PAID PRICE
- $50/month per selected monitoring service
- STATUS
- Historical-data validation build; scheduled production monitoring is not running.
STATUS / 24 AUG 2026What exists.
What exists.
What does not.
DEMONSTRATED
Data, matching, alerts, and briefing pipeline
The repository contains a working ingestion and matching path tested against historical public FDA data.
DESIGNED BOUNDARY
Source facts stay outside model authorship
The model selects and orders from prepared facts; validation rejects references outside that set.
NOT RUNNING
Scheduled production monitoring
The current data came from a historical backfill. A production scheduler and operating process still need deployment.
NOT CLAIMED
Customers, outcomes, or complete coverage
There are no paying customers and no claim that every relevant regulatory event will always be found.
THE WORKFLOW / 04 STAGESA brief is the end.
A brief is the end.
The trail comes first.
Each stage has a narrower responsibility. That separation is the product’s main safety property.
Match
Apply client-specific watch terms without crossing workspaces.
Validate
Keep selected content inside the prepared fact set.
Render
Assemble a brief for professional review, not automatic advice.
INPUT SURFACEPublic records.
Public records.
Visible provenance.
01510(k) clearances
02PMA decisions
03Recalls
04Enforcement actions
VALIDATION / OPEN
Test the premise, not the pitch.
If you monitor FDA activity for clients, your workflow can tell us whether this product deserves to move from a validation build to a production service.