RegMatrix maps your products to the regulations and standards that apply in each market, finds the gaps in your documents, and tells you the morning an edition you depend on is replaced.
New edition: ISO 10993-1:2025 replaces the 2018 edition you work to. Two of your products reference it.
Live counts from the registry, refreshed daily.
Four capabilities that share one record of your products, your standards and your decisions.
The Advisor asks about your product, then lists the regulations, classifications and standards for each market with the reason and a confidence score for every item. Upload a technical file, test report or standards list and get its outdated editions, withdrawn references and missing evidence.
Search every ISO deliverable and the FDA recognized list, plus the official EU, UK, Canadian, Chinese, Japanese and Australian lists you load. See the current edition, drafts in progress, and what replaced what.
Add the standards you work to, paste a list, or import your library. Each morning the monitor compares them with the registry and the pages you choose to watch, then alerts you in the app and by email, instantly or as a digest.
Record the standards your company holds, with licence type, seats and expiry. Missing one? Go to the publisher's store for that exact designation, or let the order desk buy it under a licence in your company's name.
Sample rows use real standards; product details are illustrative. Every report exports to Excel, Word or CSV, and the AI reads PDFs, Office files, scans and photos.
ISO Open Data and the FDA recognized list are reloaded. Only entries that changed are rewritten.
Each standard you watch is checked for a new edition, amendment, withdrawal or draft, and any page you asked us to watch is re-read.
In the app, and by email instantly or in your daily or weekly digest. High-severity changes are also noted in your workspace memory.
Open the affected products, re-run the gap check and record a reviewer's decision. Every decision lands in the audit trail.
Two sources refresh themselves daily. The regulator lists load from the file each authority publishes, so you see exactly what the regulator listed.
| Source | Region | How it updates | Listed now |
|---|---|---|---|
| ISO — all deliverables (ISO Open Data)INTL | INTL | Daily, automatic | 34,758 |
| FDA Recognized Consensus Standards (medical devices)US | US | Daily, automatic | 1,738 |
| EU harmonised standards — Regulation (EU) 2017/745 (MDR)EU | EU | From the official file | — |
| EU harmonised standards — Regulation (EU) 2017/746 (IVDR)EU | EU | From the official file | — |
| EU harmonised standards — Directive 93/42/EEC (MDD, legacy devices)EU | EU | From the official file | — |
| EU harmonised standards — Directive 90/385/EEC (AIMDD, legacy)EU | EU | From the official file | — |
| EU harmonised standards — Directive 98/79/EC (IVDD, legacy)EU | EU | From the official file | — |
| UK designated standards — medical devices (MHRA)UK | UK | From the official file | — |
| Health Canada — List of Recognized Standards for Medical DevicesCA | CA | From the official file | — |
| China NMPA — medical device standards catalogue (GB / YY)CN | CN | From the official file | — |
| China national standards (SAMR / SAC)CN | CN | From the official file | — |
| Japan — certification standards & JIS for medical devices (MHLW / PMDA)JP | JP | From the official file | — |
| Japan Industrial Standards (JISC)JP | JP | From the official file | — |
| Australia TGA — medical device standards ordersAU | AU | From the official file | — |
“Listed now” counts entries that are not withdrawn or cancelled. A dash means the list is supported and not yet loaded.
We keep designations, titles, editions and our findings. Clause comparisons run on your licensed copy and keep only clause numbers and verdicts.
The AI proposes; a named reviewer approves or rejects. Decisions are append-only and export as a traceability report.
Connect your own Anthropic or OpenAI key, stored encrypted, or use ours. With your own key, nothing falls back to ours.
Uploads, including scans the AI reads page by page, are removed from storage as soon as the text is extracted.
No. Determinations are regulatory orientation to help you plan. Each one lists its assumptions and what to verify with your notified body, regulator or consultant.
Standards are sold by their publishers. We link to the official store for each designation, and our order desk can buy one for you with the publisher's price and our service fee shown separately.
ISO and the FDA recognized list update daily. The EU harmonised lists (MDR, IVDR and the legacy directives), UK designated standards, Health Canada, China NMPA and SAMR, Japan MHLW and JIS, and Australia TGA load from the regulator's official file.
Every report downloads as Excel, Word or CSV: traceability matrix, gap register, document assessment, applicability determination, watchlist, alerts and library.
PDF, Word, Excel, PowerPoint, CSV and text, plus scanned PDFs and photos, which the AI reads page by page. Files up to 50 MB.
The demo searches the live registry and walks through a sample assessment, with Excel and Word downloads. No account needed.