What It Does:
Formly is an AI-powered regulatory and compliance platform that helps medical device companies manage approvals faster by combining expert regulatory teams, AI agents trained on regulations, and an eQMS system designed for medtech compliance workflows.
Key Features:
- End-to-end regulatory support: Combines AI tools, software, and real regulatory experts in one system
- Senior ex-FDA experts: Hands-on specialists who actively manage submission work, not just advisory support
- AI regulatory agents: Assist with drafting, checking, and understanding complex regulatory requirements
- Purpose-built eQMS: A quality management system designed specifically for medical device compliance (ISO 13485 aligned)
- Multi-market support: Covers FDA (US), EU MDR/IVDR, UKCA, ISO 13485, and MDSAP pathways
- Flexible setup: Use Formly as a full regulatory team or just as a software platform
- Audit-ready documentation: Helps create, organize, and manage submission-ready regulatory files
- Secure collaboration: Built with enterprise-grade security and IP protection for sensitive medical data
Who Is Formly For?
- Medtech startups preparing their first product submission
- Medical device companies navigating the FDA and EU regulatory approval
- Regulatory affairs teams need better tools and faster workflows
- Companies that don’t have in-house regulatory leadership
- Founders who want to reduce time-to-market for medical devices
- Investors and accelerators supporting regulated healthcare innovation
Final Thoughts:
Formly stands out because it doesn’t just offer software-it combines AI tools with real regulatory experts to actively help companies get medical devices approved faster.
It’s especially valuable for teams that feel stuck in slow, traditional approval processes. If speed, compliance accuracy, and expert support matter for your product, Formly is worth exploring with a discovery call.
