What We Monitor for Digital Health & SaMD Companies
SaMD classification guidance
AI/ML predetermined change control
Digital Health Pre-Cert evolution
Software validation (CSA) updates
Cybersecurity pre-market requirements
Clinical decision support boundaries
Mobile medical app enforcement
Real-world evidence for software
International harmonization (IMDRF)
Decisions This Intelligence Affects
Product & Regulatory
- • SaMD risk classification decisions
- • 510(k) vs De Novo pathway selection
- • Predetermined change control planning
- • Clinical decision support positioning
Engineering & Quality
- • Software development lifecycle
- • Cybersecurity architecture decisions
- • Validation approach (IEC 62304)
- • AI/ML model documentation
Legal & Compliance
- • Regulatory boundary assessment
- • Enforcement discretion interpretation
- • Data privacy intersection (HIPAA/FDA)
- • International market access
Executive & Investor
- • Regulatory pathway credibility
- • Time-to-market risk assessment
- • Competitive landscape shifts
- • M&A and partnership due diligence
How Digital Health Teams Use This Intelligence
Navigate AI/ML Guidance
Understand predetermined change control before building model update processes
Optimize SaMD Classification
Track IEC 62304 and IMDRF framework evolution
Accelerate Regulatory Decisions
Pre-interpreted guidance reduces internal analysis by 60%+
Monitor Enforcement Boundaries
Understand where FDA discretion ends and enforcement begins
Brief Investors Confidently
Cite regulatory intelligence in fundraising and board discussions
Support Pre-Sub Preparation
Align questions with current FDA thinking before meetings