Build compliant medical software. Faster.
ExtraHorizon is the backend platform purpose-built for regulated medical software — so you can ship IEC 62304, HIPAA, and MDR-compliant products without building infrastructure or API's from scratch.
Trusted by leading MedTech companies worldwide
Product
Everything you need to ship
One platform. Three pillars. Built for the complexity of regulated healthcare software.
Solutions
Built for every use case
From remote patient monitoring to AI-powered diagnostics — ExtraHorizon handles the backend so your team can focus on the product.
Remote Patient Monitoring
Track patient vitals and health data in real time.
Software as a Medical Device
Build and ship IEC 62304-compliant SaMD.
Medical Imaging
Store, process, and annotate medical images.
Clinical Decision Support
Deliver evidence-based guidance at point of care.
AI & ML
Deploy and validate AI models in regulated environments.
Data Encryption
End-to-end encryption that meets HIPAA & GDPR.
Data Analytics
Aggregate and visualise clinical data at scale.
Built for compliance
Regulation-ready from day one.
ExtraHorizon is independently audited and certified against the most demanding medical device and data security standards — so you don't have to start from scratch.
View all certifications →ISO 27001
Information security
ISO 13485
Medical device QMS
IEC 62304
Software lifecycle
ISO 27701
Privacy management
GDPR
EU data protection
HIPAA
US health data privacy
Ready to build your medical software?
Join the MedTech teams building compliant, scalable products on ExtraHorizon.