Design controls, predicate search, and regulatory research in one platform. PrediClear cuts time-to-regulatory-readiness from 6 months to 3 — so your device gets to market while the window's still open.
Built for biomedical engineers and regulatory professionals who are done with spreadsheet traceability.
Five capabilities that replace the spreadsheet maze, the shared drives, and the $50K/year document management tool.
Choose your target markets — FDA, EU MDR, Health Canada, TGA — and PrediClear auto-populates every applicable standard, guidance document, and regulatory pathway. No more hunting through databases to figure out what applies.
A living traceability matrix that links user needs to design inputs, design outputs, V&V protocols, and risk controls. Every thread is traceable. Every gap is visible. Auditors see a system, not a spreadsheet.
Version-controlled, audit-ready document storage organized by project. Every revision tracked, every change logged. When the auditor asks "show me version 3 of the risk analysis" — you pull it up in seconds, not hours.
Search across FDA 510(k) databases, predicate devices, competitor submissions, published research, and regulatory guidance — all from one query. PrediClear surfaces the predicates that matter, the standards that apply, and the competitive landscape you need to understand. Stop toggling between AccessGUDID, PubMed, and the FDA search portal.
PrediClear builds institutional knowledge across your projects. It learns your device category, your regulatory history, your risk tolerance — and gets smarter with every submission. When standards change, your projects update automatically.
Legacy QMS platforms were built to store files. PrediClear was built to think about regulatory strategy.
Existing tools treat regulatory as a filing problem. You upload documents, check boxes, and hope the auditor doesn't ask hard questions. PrediClear treats regulatory as a research and engineering problem — because that's what it is.
PrediClear is in early access. Join the waitlist and be first to replace your spreadsheet traceability with AI-powered regulatory intelligence.