Skip to content

Our Capabilities

Integrated engineering for connected, regulated medical devices, from silicon to cloud.

We help MedTech teams reduce technical, regulatory, and cybersecurity risk across complex Class II and III medical devices, combining deep domain expertise, compliance-aligned execution, and end to end engineering delivery.

Compliance & Quality

Compliance is part of how systems are planned, built, verified, and documented, not something added at the end. We develop medical device software under IEC 62304, with FDA QMSR design and development practices and ISO 14971 risk-driven engineering throughout.

  1. Planning
  2. Development
  3. Verification
  4. Submission

  • Standards-Aligned Development

    IEC 62304, FDA QMSR design and development, and a structured SDLC aligned to regulated delivery.

  • Risk Management & Traceability

    Requirements, architecture, testing, and documentation connected through ISO 14971 risk-based engineering decisions.

  • Verification & Validation

    Rigorous unit testing, verification and validation workflows, and evidence generation built into development.

  • Pre-Market Cybersecurity Readiness

    Security risk management, cybersecurity testing, and vulnerability assessment across device and cloud, aligned to FDA cybersecurity guidance, MDCG 2019-16, and IEC 81001-5-1.

  • Documentation Built for Review

    Traceable documentation that reduces friction during downstream review, validation, and submission preparation.

  • Market Approval Guidance

    Strategic consultancy that helps medical device companies plan toward market approval and launch.

Embedded Firmware

We develop robust embedded firmware for connected and safety-critical devices, from board bring-up and low-level drivers to real-time behavior and system control, in tightly constrained environments where reliability and efficiency matter most.

  1. Bring-up
  2. Drivers
  3. Real-time architecture
  4. Integration
  5. Verification

  • Bare-Metal & Low-Level Development

    Custom bootloaders, board bring-up, low-level drivers, and hardware-facing firmware for tightly controlled device behavior.

  • RTOS & Real-Time Architecture

    Structured embedded architectures for deterministic behavior, scheduling, fault handling, and safety-critical responsiveness.

  • Sensing, Control & Communications

    Firmware for biosensing, stimulation, analog interfaces, telemetry, and embedded communications across connected device systems.

  • Platform & Silicon Breadth

    Experience across ARM-based and specialized embedded platforms, including diverse microcontrollers, SoCs, and wireless, mixed-signal, and device-specific architectures.

  • System Integration

    Firmware developed in close alignment with hardware, sensing, communications, and higher-level software for stable, end-to-end product behavior.

  • Power, Performance & Reliability

    Architectures optimized for constrained devices, ultra-low-power operation, deterministic real-time behavior, and dependable performance.

  • Verification & Documentation

    Development practices that support automated testing, verification, traceability, and documentation aligned to regulated product delivery.

Cybersecurity

We build cybersecurity into the full product lifecycle (SPDF), from architecture and design through testing, release, and post-market management. For connected medical products, security directly affects patient safety, data privacy, product resilience, and regulatory readiness.

  1. Architecture
  2. Assessment
  3. Testing
  4. Release
  5. Monitoring
  • Hardware and device
  • Firmware and RTOS
  • Application and mobile
  • Cloud and backend

  • Security Architecture

    Hardware, firmware, software, and cloud security architecture reviews that find weaknesses early and strengthen product security before release.

  • Security Risk Assessment

    Asset identification, threat modeling, design-stage vulnerability assessment, and formal risk assessment outputs for risk-aware development.

  • Secure Software & Firmware Design

    Secure design and implementation support for firmware and software, including wireless security, security controls, and targeted remediation guidance.

  • Cybersecurity Testing

    Vulnerability testing, penetration testing, and security control verification across devices and their connected backends.

  • Supply Chain & SBOM Support

    Machine-readable SBOM generation, detection of known vulnerabilities, and clear visibility into the software supply chain.

  • Post-Market Security Management

    Proactive monitoring, reassessment, remediation support, and coordinated vulnerability disclosure that keep products secure after launch.

Applications, Cloud & Human Factors

Applications, portals, and cloud platforms built on a reusable, compliant foundation. Human factors engineering under IEC 62366-1 keeps interfaces clear for clinicians and patients and reduces use error in safety-critical systems.

  1. Apps
  2. Portals
  3. Cloud
  4. Analytics

  • Clinician & Patient Applications

    Tablet, mobile, and kiosk applications designed for clinician workflows, patient interaction, and connected device operation.

  • Web Portals & Operational Interfaces

    Secure portals for healthcare professionals, administrators, and internal teams to manage workflows, visibility, and product operations.

  • Secure Silicon-to-Cloud Pipelines

    Cloud-connected architectures for data ingestion, remote monitoring and programming, analysis, and reporting.

  • Future-Ready Digital Foundation

    New applications connect to an established foundation for identity, security, and compliance, so those layers aren't rebuilt from scratch.

  • Regulatory Agility

    Patient engagement kept separate from safety-critical SaMD, so application updates move faster without unnecessary revalidation cycles.

  • Global Data Strategy

    Cloud architectures that support regional deployment, privacy boundaries, and compliant operations as global requirements evolve.

  • Human Factors by Design

    User-centric interfaces that reduce use error, improve usability, and support safer workflows in complex systems.

  • Analytics & Operational Visibility

    Data platforms for reporting, analysis, and insight across product, clinical, and R&D teams.

Hardware & System Design

Hardware and system design across the full product journey, from early feasibility through architecture, prototyping, integration, and validation. We focus on complex devices where electronics, mechanics, firmware, sensing, actuation, and usability must work together as one system.

  1. Feasibility
  2. Electronics
  3. Sensors
  4. Prototyping
  5. Validation
  6. Manufacturing readiness

  • System Architecture & Feasibility

    Product conception, feasibility analysis, and system studies that define a viable path from idea to implementable device architecture.

  • Electronics & Embedded Design

    Hardware and embedded firmware designed together for reliable system behavior and integration.

  • ASIC & Platform Definition

    ASIC definition, specification, and design management for programs that need custom silicon or specialized platform coordination.

  • Sensor & Signal-Chain Interfaces

    Biosensing, actuation, and analog interface design, with the signal-chain care precise device behavior needs.

  • Mechanical Design & Prototyping

    Mechanical design, medical-grade 3D printing, and iterative prototyping to refine usability, packaging, and product fit.

  • Testing, Validation & Documentation

    Structured testing, validation, and technical documentation under IEC 60601 to support product maturity and regulated development.

  • Manufacturing Readiness

    Vendor coordination, manufacturing setup, ISO-certified cleanroom assembly, pilot builds, and support through low-volume and contract manufacturing.

  • Validation & Clinical Evaluation Support

    Participation in system validation and in pre-clinical and clinical evaluation that moves products toward real-world use.

Schedule your 1-hour technical deep-dive

A complimentary, no-obligation strategy session. Questions of any size are welcome too.

What we'll review

  • Your requirements
  • Your desired architecture
  • Key safety, regulatory and cybersecurity risks
Follow us on LinkedIn