Build FDA-Cleared AI Into Your Medical Device.
Zabrizon's SaMD development platform delivers AI inference engines, IEC 62304-compliant software lifecycle management, and FDA regulatory pathway support — accelerating time-to-clearance for medical device companies.
Medical Device AI Platform Capabilities
From embedded AI inference to regulatory submission — a complete SaMD development partner.
Edge AI & Embedded Inference
Optimised AI model deployment on medical device hardware — from wearables to Class III imaging systems — with quantisation, pruning, and real-time performance guarantees.
IEC 62304 Software Lifecycle Management
Complete software development lifecycle documentation for FDA and EU MDR requirements — requirements management, architecture, V&V testing, and change management.
AI Model Validation & Post-Market Surveillance
Clinical validation protocols for AI/ML models including algorithm change protocols and real-world performance monitoring required for FDA predetermined change control.
Why HealthTech Companies Choose Zabrizon for SaMD
Technical depth meets regulatory expertise — a combination most AI firms can't offer.
FDA Pre-Submission Strategy
We help clients structure FDA Q-Sub meetings and pre-submission packages that de-risk regulatory pathways before major development investment.
Explainable AI for Clinical Devices
FDA increasingly requires explainability for AI-based clinical decisions — our XAI layer provides heatmaps, confidence scores, and decision rationale for every inference.
Cybersecurity for Medical Devices
FDA-aligned cybersecurity controls per the 2023 Cybersecurity Guidance — SBOM, vulnerability management, and patch deployment protocols for connected devices.
Cloud-Connected Device Data Platform
Secure cloud infrastructure for real-world device data collection, model retraining pipelines, and population-level performance analytics.
Regulatory & Security Standards
Built to satisfy FDA, EU MDR, and international medical device requirements.
Ready to Build and Clear Your AI Medical Device Faster?
See how Zabrizon's SaMD development platform and regulatory expertise accelerate your path to FDA clearance.