Pure Global MedTech versus Formly
Pure Global MedTech
Ideal For
Assisting companies in regulatory submissions
Helping navigate FDA and international regulations
Providing strategies for clinical trial compliance
Streamlining processes for faster market entry
Key Strengths
Expert guidance in regulatory challenges
AI-enhanced decision-making
Streamlined compliance processes
Core Features
Medical device regulatory consulting
AI-driven global market access strategies
Efficient regulatory compliance solutions
Expert team assistance
Comprehensive navigation of compliance requirements
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