FormlyAI is a specialized AI tool that streamlines the complex process of medical device certification and compliance in the EU and US. It offers automated documentation, regulatory guidance, and QMS creation to help businesses meet industry standards efficiently.
FormlyAI is an AI-powered software designed to simplify and expedite the medical device certification process, particularly for startups. It helps companies achieve EU and US medical device compliance by offering tools for creating and managing required documentation, expert regulatory guidance, and AI-backed documentation writing. The platform supports various standards such as MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366. It is ideal for businesses looking to get their medical devices certified efficiently and cost-effectively.
A.Medical device certification ensures that your product meets safety, health, and environmental protection requirements. In the EU, it involves obtaining a CE mark, while in the US, it requires FDA approval or clearance. Certification is crucial for legal market access and consumer trust.
A.The certification process involves determining product risk class, establishing a Quality Management System (QMS), creating technical documentation, undergoing an audit (if required), and maintaining post-market requirements.
A.FormlyAI covers all standards required for EU and US market compliance, including EU MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62366, and IEC 62304.
A.Yes! Formly's software is built for everyone, including those unfamiliar with medical device regulations. The Document Autopilot generates MDR and FDA compliant documents, and built-in descriptions and video walk-throughs guide you through the rest.
A.You can’t be too early but you can be late. Once you understand what product you want to build, you can start your certification journey.
