MarketReady AIMDSAP-aligned · FDA · Health Canada · EU MDR
Build your evidence once. Open markets in every country you sell.
MarketReady AI ties one ISO 13485 / MDSAP quality system to the submission each regulator expects — FDA eSTAR, a Health Canada licence, an EU MDR technical file — so you can go global without rebuilding the dossier every time.
eSTAR 510(k) · De Novo · PMA
21 CFR 820 (QMSR)
MDL dossier · Class I–IV
SOR/98-282 s.32
Technical documentation
Annex II & III
One audit, recognized by five regulators
ISO 13485:2016
One audit. Five regulators. Three dossiers.
The Medical Device Single Audit Program lets one QMS audit satisfy the US, Canada, Australia, Brazil and Japan — and it is mandatory for a Health Canada licence. MarketReady AI keeps your controlled documents in that single structure and maps each record to every market's checklist.
- Upload a risk file, design history or test report once
- Map it to eSTAR sections, s.32 items and Annex II at the same time
- See readiness per market, by device class
- Spot which gaps block which country before you file
Built for connected and AI-enabled devices
Flag AI/ML submissions and work against FDA PCCP guidance and IMDRF Good Machine Learning Practice (N88).
FDA 2026 cybersecurity guidance, IEC 81001-5-1, IMDRF N60/N70 and NIST frameworks — threat models, SBOM and §524B evidence.
Pull new Federal Register notices on demand and see which active AI/ML submissions they may affect.
Answers drawn only from your vetted standards library, scoped to the market you're filing in, with a source for every claim.
More than a document generator
| Capability | MarketReady AI | US-only AI writers |
|---|---|---|
| US, Canada and EU dossiers from one evidence base | ||
| MDSAP / ISO 13485 aligned evidence reuse | ||
| Human approval before anything counts as evidence | ||
| Full audit trail for every change | ||
| Answers cite the exact standard or guidance | ||
| AI/ML and cybersecurity specific checklists |
Plan your multi-market launch with evidence you can defend.
Get startedMarketReady AI is an internal preparation and evidence management tool. It is not authorized by any regulator, does not make regulatory decisions, and does not replace qualified regulatory affairs professionals.
by LoweRiskQA Consulting Inc.