Formlyai
Formly is an AI-powered software designed to simplify and expedite the medical device certification process, particularly for startups. It offers tools for creating and managing required documentation, expert regulatory guidance, and AI-backed documentation writing to help companies achieve EU and US medical device compliance and get to market quickly and on budget. Formly supports various standards including MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
AI-powered software for medical device certification and compliance in the EU and US.
- Achieving EU CE mark certification for medical devices
- Obtaining US FDA approval/clearance for medical devices
- Creating and maintaining ISO 13485 compliant QMS
- Building audit-proof technical documentation
- Managing document approval and revisions
- Use Formly to create and manage medical device documentation
- access expert regulatory guidance
- and leverage AI to automate documentation writing. The platform guides users through the certification process
- from determining product risk class to maintaining post-market surveillance.
AI-powered platform for creating presentations, webpages, and documents with minimal design effort.
An all-in-one AI workspace for automating business documents, presentations, and meeting productivity.
AI-powered document conversion for various formats.
AI platform for creating product videos and documentation from screen recordings.
AI generator for fully editable, production-ready branded documents and professional assets.
AI video editor for marketing teams to create product videos and documentation quickly.
A single source of truth for technical documentation with AI-powered search.
AI copilot for product managers to write product documentation quickly and efficiently.
