What is Formly?
Formly is an AI-powered software solution designed to streamline medical device certification and compliance processes for the EU and US markets. This innovative tool leverages advanced artificial intelligence to automate complex regulatory tasks, ensuring accuracy and efficiency throughout the compliance journey. Formly serves as a comprehensive platform that helps medical device companies navigate intricate regulatory landscapes, reduce compliance risks, and accelerate product launch timelines through intelligent automation and real-time monitoring.
How to use Formly?
Using Formly involves a straightforward, step-by-step process. First, users input their medical device details and regulatory requirements into the platform. Formly's AI engine then analyzes this information and provides tailored regulatory guidance specific to the target markets. The system automatically generates compliant documentation based on the latest regulatory standards. Users can track their compliance progress in real-time through an intuitive dashboard, receive alerts for upcoming deadlines, and access automated reporting features. The platform also offers collaboration tools for team members to review and approve documentation before submission to regulatory authorities.
Core features of Formly?
Formly offers several powerful features to enhance medical device compliance management:
- AI-Powered Regulatory Guidance: Provides real-time, market-specific regulatory updates and compliance recommendations based on your device classification and intended use.
- Automated Documentation Generation: Creates complete, compliant technical files and regulatory submissions with minimal manual input, reducing errors and saving time.
- Real-Time Compliance Dashboard: Offers visual tracking of compliance status across multiple regulatory pathways with automated progress indicators and risk assessments.
- Multi-Market Support: Seamlessly manages compliance requirements for both EU (MDR/IVDR) and US (FDA) markets within a single platform.
- Intelligent Risk Assessment: Uses AI to identify potential compliance gaps and suggests corrective actions before submission to regulatory bodies.
