We engineer regulated medical products end-to-end, including custom hardware architecture, embedded systems, and enterprise-grade mobile and medical software.
Custom medical hardware & electronics
Embedded firmware & device integration
Enterprise mobile & regulated medical software
Medical Device Manufacturers • Regulated Environments • NDA-First Engagements
NDA available · Direct engineer-to-engineer · Technical discussion only
Full product responsibility from system architecture to production readiness.
Custom medical electronics design, PCB development, prototyping, component selection, and device-level architecture engineered for regulated environments and manufacturability.
Real-time firmware development, RTOS integration, sensor interfaces, device communication protocols, and secure system-level integration.
Product-level system design, requirement decomposition, hardware–software boundary definition, risk-aware architecture, and feasibility validation before implementation.
System validation, traceability documentation, risk analysis support, design verification planning, and preparation for manufacturing and regulatory pathways.
Prototype-to-production transition, hardware refinement, integration testing, supplier coordination, and production readiness engineering.
Native iOS and Android applications, secure device connectivity, backend systems, and regulated medical software aligned with hardware architecture.
We assume architectural and system-level responsibility across the full product lifecycle.
Structured execution model for regulated medical device programs.
Program objectives, constraints, regulatory context, and system boundaries are defined. High-level architecture, interface contracts, and a risk framework are established before implementation.
Custom electronics, firmware architecture, signal integrity, power constraints, and hardware validation strategy are developed in parallel with system-level controls.
Connectivity, mobile, and enterprise software are engineered around device constraints, security requirements, and data integrity — with regulated workflows in mind.
Requirements traceability, verification artifacts, documentation structure, and risk controls are organized for audit readiness.
Engineering decisions are aligned with manufacturing, deployment, maintainability, and controlled long-term evolution.
Confidentiality structured from project inception.
Security, privacy, and protected health data considerations embedded into system design.
Development structured around design controls, risk analysis, and verification practices.
Medical device workflows aligned with European regulatory expectations.
Quality management principles reflected in engineering processes.
Medical device quality system requirements considered during development.
Requirements, decisions, and verification artifacts structured for review.
Engineering accountability, regulated execution, and hardware-first system design.
Clear system architecture, explicit boundaries, and documented engineering decisions from day one.
Embedded and device constraints drive software and mobile architecture across the program.
Work structured around traceability, risk analysis, verification strategy, and production readiness.
Turnkey execution from hardware and embedded firmware through connectivity, mobile, and enterprise medical software — delivered as one cohesive system.
Direct technical collaboration with accountable engineers owning scope, risk, and execution.
Systems structured for manufacturability (DFM/DFA), maintainability, and long-term lifecycle support.
Full-cycle engineering engagements — from system architecture and hardware development to verification and production readiness.
Full-Cycle Medical Device Engineering with Architectural Responsibility.
We design and deliver regulated medical systems end-to-end — from hardware architecture and embedded firmware to mobile and enterprise medical software.
We define system architecture, boundaries, interfaces, and long-term behavior from the outset. Engineering decisions, constraints, and trade-offs are explicit, documented, and traceable.
Collaboration is direct and technical. Engagements are led by engineers with clear ownership of scope, risk, and execution. Work remains auditable, maintainable, and production-ready.
Traceability, risk analysis, verification strategy, and failure-mode consideration are integrated into development from day one. Systems are structured for compliance, manufacturability, and lifecycle support.
We execute across hardware design, embedded systems, connectivity, mobile applications, and enterprise medical platforms — delivering cohesive, production-ready devices and connected systems.
NDA available · Technical discussion only · No sales pitch
Direct engineer-to-engineer discussion. Structured technical intake.
NDA available prior to disclosure.
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Your submission is reviewed by a senior engineer within 24–48 hours.
Direct technical discussion to clarify scope, constraints, and system boundaries.
Mutual NDA executed prior to detailed technical exchange.
High-level system structure, risks, and next-phase recommendations.