Trusted Partner for SaMD & Digital Health Companies
Why SaMD Companies Need a Different Regulatory Approach
Software as a Medical Device requires more than a one-time submission. It requires continuous compliance checks as software updates. Today’s regulatory expectations extend across classification, clinical/performance evidence, cybersecurity, software lifecycle controls, algorithm updates, and post-market change management.
Freyr helps SaMD innovators build a practical, submission-ready pathway that aligns product intent, evidence strategy, quality systems, and regional market requirements from day one.

What You Gain

How We Support Your SaMD Journey
Assess product intent, claims, and classification
Develop software and testing protocols
Define the right US, EU, or global regulatory strategy
Prepare technical documentation, evidence, and quality-system inputs
Submit with market-specific regulatory support
Sustain compliance through post-market, cybersecurity, and change management

Who This Is For

SaMD startups preparing for first-market entry
Medtech companies, Pharmaceutical companies, Cosmetic companies, Software Development Companies and Hospitals with a Digital Health Portfolio
Digital health companies expanding from one region to another
AI/ML software teams needing a compliant update strategy
MedTech companies remediating QMS or strengthening submission readiness
Global teams building a multi-market expansion roadmap




