Pricing
Use FormlyAI for free with your whole team to get an ISO 13485 compliant Quality Management System. Upgrade to certify your product as medical device and on the market. Covers all EU MDR and US FDA requirements.
Free
$0
Free for everyone
Unlimited members
ISO 13485 QMS
eQMS
Import existing documentation
Document export
Auto compliance updates
Basic
$399per product/month
Billed yearly
All Free features +
Everything for EU MDR, IVDR and/or US FDA
All device types & classes
AI Agent for initial certification & ongoing compliance
Self-service
Technical support
Premium
$699per product/month
Billed yearly
All Basic features +
Dedicated Formly consultant
Regulatory strategy
Audit support
Direct messaging with expert
Video calls with expert
PRRC
Custom templates
Enterprise
Custom pricing
Annual billing only
All Premium features +
Custom pricing
Full service certification
Unlimited workspaces
Custom features
Priority support