
Healthcare AI Solutions
Clinical AI Built for Regulatory Standards
From ambient documentation to diagnostic assistance
We develop AI systems for healthcare organizations following FDA/CE guidance and best practices. Our solutions aim to reduce documentation burden, support clinical decision-making, and scale to enterprise needs while prioritizing patient safety and regulatory alignment.
Complete AI Solutions for Clinical Teams
We deliver end-to-end AI systems designed to integrate with clinical workflows. From LLM-powered documentation to computer vision for medical imaging, we provide comprehensive development services and regulatory documentation support.
AI Model Architecture
Clinical AI Pipeline Visualization
Inference Speed
Optimized
Accuracy
Validated
Capacity
Scalable
Availability
High
Enterprise-Grade Technology Stack
Built with healthcare-specific frameworks and FDA-validated tools
From Concept to Regulatory-Ready Deployment
Our structured 5-phase implementation process for healthcare AI solutions
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Clinical Needs Assessment
Deep dive into your clinical workflows, data infrastructure, and regulatory requirements. We interview stakeholders, analyze existing systems, and define success metrics tailored to healthcare environments.
AI Model & Platform Build
Develop and train AI models on your clinical data. Build secure, scalable infrastructure with real-time inference capabilities, comprehensive monitoring, and full HIPAA compliance.
Clinical Validation & Testing
Rigorous testing against clinical datasets, performance benchmarking, and safety validation. We prepare comprehensive V&V documentation following FDA guidance for AI/ML medical software.
Regulatory Documentation Support
Prepare comprehensive technical documentation aligned with FDA guidance including software description, cybersecurity assessment, and clinical evaluation support for regulatory submissions.
Production Launch & Support
Deploy to production environment with comprehensive monitoring, alerting, and 24/7 support. We train your clinical teams and establish ongoing maintenance protocols for sustained success.
Compliance & Security
Built to meet the highest regulatory standards
FDA Guidance
Aligned with FDA AI/ML guidance
HIPAA
Protected health information security standards
IEC 62304
Following medical device software lifecycle
ISO 13485
Following quality management standards
CE MDR
Aligned with European regulatory standards
UKCA
Aligned with UK regulatory standards
SOC 2 Type II
Security and availability controls
GDPR
EU data protection compliance
All systems undergo rigorous security audits and penetration testing
Ready to Transform Clinical Workflows?
Join leading healthcare organizations using AI to improve patient care while reducing clinician burnout
Free consultation • Regulatory guidance • No commitment required
Other Services
Explore our complete range of healthcare technology solutions
Medical Device Platforms
End-to-end platforms connecting devices to clinical insights. Real-time data processing, device management, and analytics at scale. Designed for ISO 13485 and FDA compliance from day one.
Learn moreFirmware & Embedded Systems
Mission-critical firmware with bulletproof reliability and real-time performance. From wearables to implantables, we handle Class II/III devices. IEC 62304 compliant with complete V&V documentation.
Learn moreMobile & Web Applications
Patient apps people actually use and clinicians trust. Telemedicine platforms, wellness trackers, and clinical workflows. Beautiful design with HIPAA compliance built in.
Learn moreEnterprise IT Solutions
Transform fragmented healthcare IT across multi-site health systems. Legacy modernization, EHR integration, and cloud migration. Scale to millions of patients with 99.99% uptime.
Learn moreInternal Research Tools
Custom tools that automate workflows and deliver real-time insights. Clinical trial management, operational dashboards, and research platforms. Built specifically for your team's processes.
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