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.
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