Formly
Ideal For
Streamline documentation for CE marking of medical devices
Accelerate time to market for software as a medical device (SaMD)
Simplify regulatory compliance for startups
Assist manufacturers in maintaining compliance
Key Strengths
Streamlined compliance process
Reduced time to market
Expert regulatory support
Core Features
AI-generated MDR compliant documentation
One-click technical file generation
Tailored roadmap for CE marking
Expert regulatory guidance and support
Automated compliance updates