FormlyAI is a virtual Chief Regulatory Officer, designed to help medical device companies navigate the complex landscape of regulatory compliance. It combines AI efficiency with human expertise to streamline the certification process for various medical devices, including implants, digital therapeutics, and cancer diagnostics.
Key Features:
- Comprehensive Certification Coverage: Supports ISO 13485, 21 CFR, MDR 2017/745, and IVDR 2017/746, along with associated consensus standards.
- Clear Certification Roadmap: Identifies and implements all compliance requirements specific to the device.
- AI-Powered Efficiency: Automates tasks and provides guidance, reducing the time and resources needed for compliance.
- Dedicated Expert Support: Offers access to a team of seasoned regulatory experts for guidance and support.
- Post-Market Surveillance: Monitors device performance and safety after market release.
- Scalable Compliance: Manages compliance for multiple devices across different continents.
Use Cases:
- Pre-Certification: Helps companies get their medical devices to market quickly with a fixed-fee regulatory support package.
- Post-Certification: Ensures ongoing compliance with an annual fee, offering services from self-managed to fully outsourced solutions.
- Quality Management System (QMS): Provides a fully managed QMS to meet regulatory requirements.
- Technical Documentation: Assists in creating and maintaining necessary technical documentation.
- eQMS: Offers an electronic QMS for efficient management of compliance processes.
