PRODUCTS

Formly QMS PlusAn eQMS that creates documents, not just stores them
Formly AgentAI submission drafting with verifiable citations
Formly TandemCo-pilot for cross-functional regulatory teams

FEATURED

See Formly Agent in action2 min preview

CUSTOMERS

StartupsFrom eligibility to clearance, fast
Regulatory TeamsReduce QMS overhead, stay audit-ready
InvestorsDiligence-ready data rooms on demand

FEATURED

How Acme Surgical cleared in just 8 weeksCustomer story · 4 min read

RESOURCES

Free toolsEligibility checker, class calculator
CompanyAbout FormlyAI and the team
CareersOpen roles and company updates
BlogInsights for medtech operators
Case studiesReal medtech submissions and market timelines
TrustSecurity, compliance, live status

FEATURED

The 510(k) AI prep playbookNew article · 8 min read

Login Start free trial

CONTACT

Schedule a meeting

Talk to our team to discuss your product, regulatory path, and next best step

Or ask us a question at hello@formly.ai.

Email address

PRODUCT

Formly QMS Plus
AI Agent
Formly Tandem
Pricing

CUSTOMERS

Startups
Regulatory Teams
Investors

RESOURCES

Free tools
Blog
Case studies
Glossary
Trust Centre

CONNECT

Contact
Login
Support
Developers

COMPANY

About Us
Careers

© 2026 Formly Health · Built for medtech operators · Made in Berlin

Terms & Conditions Privacy Policy

SOC 2 Type II · ISO 27001 · GDPR