Classification Engine Dual-market
The FDA and EU MDR engines are independent. Use the market selector above. “Both + Compare” shows results side-by-side with a divergence summary.
FDA Classification & Pathway
After estimating class/pathway, look up the official product code and 21 CFR regulation number in the FDA Product Classification database. That determines the exact controls, exemptions and guidance.
SaMD / AI IMDRF + FDA + MDR
The IMDRF risk framework is the common language. Map the result to the FDA pathway and MDR Rule 11.
EU AI Act Regulation (EU) 2024/1689
The AI Act applies in addition to the MDR for AI-enabled medical devices. An AI system that is a device (or a safety component of one) requiring Notified Body conformity assessment under the MDR is high-risk under Article 6(1).
Cybersecurity FDA + MDR
FDA
EU MDR / MDCG 2019-16
Human Factors / Usability FDA + MDR
GSPR Matrix EU only
0 / 0
| ID | Requirement | App. | Note | Status |
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EUDAMED Completeness EU
Summary Report
Compiles every module you have run into a single summary. Use Print / PDF to keep a record.
About RegCompass
RegCompass is a free, dual-market decision-support toolkit for FDA (US) and EU MDR medical-device requirements. It covers classification, SaMD/AI (IMDRF-aligned), the EU AI Act, cybersecurity, human factors, GSPR and EUDAMED completeness. It does not replace professional regulatory advice, FDA interaction or Notified Body assessment.
RegCompass contains no artificial-intelligence, machine-learning, or third-party AI-assistant code of any kind — no embedded copilot, chatbot, model API calls, or AI-generated runtime logic. Every result is produced by fixed, human-written decision rules that you can read and audit line-by-line in the open-source code (
js/app.js). The app runs entirely on your device, works offline, and collects or transmits no data. This applies to the build and packaging scripts too (electron/main.js, scripts/make-www.js, the GitHub Actions workflows) — there is no AI anywhere in the toolchain that ships to users.
RegCompass is provided "as is", without warranty of any kind, express or implied. It may contain errors or omissions and is not a substitute for professional regulatory advice. No liability is accepted for any decision made or action taken using this tool. Classification, pathway selection and compliance remain the sole responsibility of the manufacturer. Results are preliminary. Always verify against official FDA resources, EUR-Lex, current MDCG guidance, IMDRF documents and EUDAMED.
Official sources
Install as an app
RegCompass is an installable web app (PWA). On phones use “Add to Home Screen”; on desktop Chrome/Edge use the install icon in the address bar.
Windows desktop app
No install needed to try it — the portable build runs directly. The installer adds a Start Menu shortcut and auto-updates in place.
The .exe is unsigned (code-signing certificates are a paid service), so Windows SmartScreen may show “Windows protected your PC” the first time. Click More info → Run anyway. Verify you downloaded from github.com/rajeevyadav/regcompass before doing so.