Global Regulatory Classifier

Stop guessing
your device's
risk class.

DeviceCompass classifies medical devices across EU MDR, IVDR, FDA and ISO 14971 in minutes — using AI-guided decision trees built by regulatory affairs experts. Audit-ready results, every time.

✓ Free to join. 3 free classifications on launch.
4Frameworks
22+MDR Rules
AIInterpretation
Device to classification flow
Why DeviceCompass

Built for people who can't afford to get it wrong.

AI-Guided Classification
AI-Guided Classification
Describe your device in plain language. Our AI interprets it and routes you to the correct regulatory branch — no need to decode Annex VIII yourself.
POWERED BY CLAUDE
Audit-Ready Reports
Audit-Ready Reports
Every classification generates a full decision trail — question by question, rule reference by rule reference. Export as PDF for your technical file.
PDF EXPORT
Multi-Jurisdiction
Multi-Jurisdiction
Run your device through EU MDR, IVDR, FDA and ISO 14971 in a single session. See how classifications differ across markets.
4 FRAMEWORKS
Hybrid Decision Logic
Hybrid Decision Logic
Path-based logic for MDR and FDA. Weighted risk scoring for ISO 14971. The right model for each framework, not a one-size-fits-all tree.
SMART ROUTING
Team & Org Support
Team & Org Support
Share classification history with your team. Admins see all sessions. Role-based access control built in from day one.
PRO & ENTERPRISE
API Access
API Access
Integrate DeviceCompass into your own QMS or product registration workflow via REST API. Enterprise plans include full API access.
ENTERPRISE
Supported Frameworks

Every major jurisdiction. One unified tool.

EU · 2017/745
EU MDR
Medical Device Regulation
Class IClass IIaClass IIbClass III
EU · 2017/746
EU IVDR
In Vitro Diagnostic Regulation
Class AClass BClass CClass D
US · FDA
FDA Classification
Federal Food, Drug & Cosmetic Act
Class I510(k)De NovoPMA
ISO · 14971
ISO 14971
Risk Management for Medical Devices
LowMediumHighCritical
Pricing

Start free. Scale as you grow.

Free
€0
forever
  • ✓3 lifetime classifications
  • ✓EU MDR only
  • ✓Basic results view
  • ✓No card required
Get started free
Starter
€29
per month
  • ✓25 credits / month
  • ✓EU MDR + IVDR
  • ✓PDF export
  • ✓Session history
  • ✓1 seat
Join waitlist
Most popular
Pro
€79
per month
  • ✓100 credits / month
  • ✓All 4 frameworks
  • ✓AI interpretation
  • ✓Team notes & history
  • ✓Up to 5 seats
  • ✓Credit top-ups available
Join waitlist
Enterprise
Custom
contact us
  • ✓Unlimited credits
  • ✓All frameworks + custom
  • ✓REST API access
  • ✓SSO / SAML
  • ✓Unlimited seats
  • ✓White-label option
  • ✓SLA + dedicated support
Contact sales
What regulatory professionals say
"We used to spend half a day walking through Annex VIII with a consultant. DeviceCompass does the same thing in under 10 minutes, with a full audit trail."
Senior RA ManagerMedical device manufacturer, Germany
"The AI interpretation is what sets it apart. I described a novel combination device in plain English and it correctly identified the Rule 11 SaMD pathway immediately."
Regulatory Affairs ConsultantIndependent consultant, Netherlands
"Having EU MDR and FDA side-by-side in a single tool is exactly what our global submissions team needed. We've already replaced two separate tools with DeviceCompass."
VP Regulatory AffairsMedTech startup, UK
Early Access

Ready to navigate
with confidence?

Join the waitlist. Get 3 free classifications on launch day. No card required.

✓ Free to join. 3 free classifications on launch.