Medical Device Software
Software as a Medical Device (SaMD) architectures adhering to IEC 62304 and ISO 13485 standards with real-time BLE telemetry.
We build compliant Software as a Medical Device (SaMD) and connected companion apps for health hardware manufacturers. From BLE continuous glucose monitoring and wearable ECG telemetry to smart pulmonary inhalers, our software delivers clinical precision with FDA compliance documentation.
Institutional Standards Embedded in Every System
We reject fragile prototypes and monolithic shortcuts. Every solution is engineered from first principles following strict enterprise Clean Architecture paradigms.
Scalable Clean Architecture
Domain-Driven Design (DDD) separating Presentation, Domain, and Infrastructure layers. Built to handle 100k+ concurrent transactions without latency degradation.
100% Sovereign IP Transfer
You own every single line of code, database schema, test suite, and cloud deployment script. $0 recurring vendor license tax.
Sub-42ms Latency SLA
Deterministic algorithmic throughput engineered with optimized database connection pooling, Redis caching, and native ARM machine code.
Air-Gapped Private VPC
Zero third-party telemetry or sensitive data egress. Deploy into your private AWS, GCP, Azure, or on-premise cloud infrastructure.
Automated Compliance Rails
Built-in continuous compliance checks adhering to strict regulatory standards (SOC 2 Type II, HIPAA, PCI-DSS Level 1, FERPA).
Native 60 FPS Ergonomics
Crafted with Material Design 3 and Apple Human Interface Guidelines, user-tested for frictionless executive and frontline adoption.
From Discovery to Sovereign VPC Handover
Our 5-stage deployment framework eliminates development ambiguity. Discover the team roles, sprints, and verified deliverables for each phase.
Discovery & Technical Specs
We dissect your existing business processes, map regulatory data flows (HIPAA, PCI-DSS, FERPA), define ACID ledger requirements, and establish the exact system architecture before writing a line of code.
Key Architecture Modules & Capabilities
Explore the core building blocks engineered into this solution to provide mission-critical reliability, compliance, and velocity.
Low-Energy Bluetooth (BLE) Telemetry
Reliable, battery-efficient connection protocols that stream real-time physiological vitals.
Clinical Signal Processing & Filtering
Digital signal processing algorithms removing noise from raw ECG, PPG, and accelerometer sensors.
IEC 62304 Software Lifecycle Process
Full traceability matrix, design history files (DHF), and risk management complying with ISO 14971.
Offline Storage & Cloud Sync
Stores vital records on-device when out of range and auto-syncs securely once reconnected.
Modern Production Tech Stack
Proven, open technologies that eliminate vendor lock-in and enable complete internal maintainability by your engineering squad.
What You Receive Upon Handover
Frequently Asked Architecture Questions
Clear, transparent answers regarding compliance, IP transfer, integrations, and pricing.
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Initiate Architecture Review for Medical Device Software
Schedule a 30-minute direct evaluation with our Principal Systems Architect or submit your project scope below.
30-Minute Architecture & ROI Review
Direct consultation with our Lead Systems Architect. We evaluate your compliance needs, latency benchmarks, and deliver a fixed-scope milestone proposal.
Guaranteed zero sales pressure. Pure technical architecture.
Request Scope & Deliverables Proposal
Our lead architect will respond with a preliminary blueprint within 24 business hours.