ElectronicsFirmwareCloudAI

From silicon to the cloud. Certification-ready.

You have a product concept, subsystem, or connected device to build. Elfstone brings the electronics, firmware, cloud, AI, mechanical, manufacturing, and regulatory support to get it built.

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Years combined experience
100+
Medical device pathways
Regulated
Silicon to the cloud
Full stack
Engineering presence
3 continents

One team carries the product from the first idea through the production line.

Services

Engineering support from device to cloud.

The work spans circuit design, firmware, cloud and on-prem platforms, security, AI where useful, regulatory coordination, and manufacturing transfer.

01

Electronics & Hardware

RF design, analog, digital, and mixed-signal design, schematic capture, PCB layout, FPGA and PLD work, and signal-integrity support for connected devices.

  • ▸RF design
  • ▸Analog & mixed-signal
  • ▸Digital
  • ▸FPGA / PLD
  • ▸PCB layout
02

Firmware & Embedded Software

Firmware, device drivers, RTOS and bare-metal systems, board bring-up, and the OS and application layers above them, with lifecycle documentation for regulated development.

  • ▸RTOS
  • ▸Bare-metal
  • ▸Device drivers
  • ▸Board bring-up
  • ▸Application layer
03

Cloud, Platform & DevOps

Device telemetry and data pipelines, OTA update paths, CI/CD, and operational tooling, on cloud or on-prem. Where the law requires it, we keep data within its jurisdiction.

  • ▸Cloud & on-prem
  • ▸Telemetry
  • ▸CI/CD
  • ▸OTA updates
  • ▸Data residency
04

Security & Data Protection

Device-to-cloud security: secure boot, encryption, access control, and audit logging, designed to support SOC 2, HIPAA, and GDPR obligations, with FIPS 140-3 validated cryptography where regulated handling requires it.

  • ▸Secure boot
  • ▸Encryption
  • ▸Access control
  • ▸FIPS 140-3
05

AI & ML Integration

Practical AI

AI and analytics where they add product value: on-device inference, monitoring, predictive signals, or operations support.

  • ▸On-device inference
  • ▸Predictive analytics
  • ▸Edge ML
06

Mechanical Design & Manufacturing Transfer

Mechanical engineering and design for manufacturing, industrial design for enclosure and form through our design partners, prototype and second-article planning, production test-fixture design, and contract-manufacturing handoff including tooling and molds.

  • ▸Mechanical / DFM
  • ▸Industrial design
  • ▸Test fixtures
  • ▸Tooling & molds
  • ▸CM handoff
07

Regulatory & Compliance Support

Verification evidence and certification-pathway support across medical, electrical, and EMC standards. We design to FCC and CE marking requirements and coordinate with external test labs and notified bodies. We are the design and compliance-readiness partner, not the certifying lab.

  • ▸IEC 62304
  • ▸ISO 13485
  • ▸FDA 510(k)
  • ▸CE / EMC
  • ▸Emissions & immunity

Built for products where failure is expensive.

Medical device laboratory

Healthcare & Medical Devices

Diagnostic hardware, connected health platforms, and medical-device subsystems built with verification and clearance pathways in mind, and data architectures that keep patient data within its required jurisdiction.

IEC 60601ISO 13485FDA 510(k)CE Pathways
Industrial IoT sensors in a factory

Industrial & IoT

Edge compute platforms, sensor networks, telemetry systems, and field hardware for equipment that needs to keep working.

IEC 62443Edge computeLPWAN
Network infrastructure cabling and patch panels

Communications & Connected Infrastructure

Signal processing, RF systems, and rugged electronics for commercial communications, connectivity, and the civilian infrastructure that has to stay up.

FPGARF systemsSignal integrity

Founder experience spans healthcare, communications, cloud, network security, and connected products.

These names reflect former employers and founder background. They do not imply current Elfstone customer relationships.

Experience working with
Medical IEC 60601IEC 62304ISO 13485FDA 510(k)CE
Electrical / EMC FCCCISPRIEC 61000RoHS
Data GDPRHIPAASOC 2

The first conversation is technical, not a pitch.

Tell us your architecture, your constraints, your unknowns. We've seen most of it before.

Start a conversation

Or email contact@elfstone.io

We work as part of your team, from first sketch to production line.

Most of what we do starts before there is a spec. We ideate with you, architect the product around what it actually has to do, and stay with it through to manufacturing. When you need to grow your own team along the way, internal or external, we help you build it.

  1. 01

    Ideate

    We start at the idea, not the spec. We separate what the proof of concept needs from what the production product needs, so you build the right thing at each stage.

  2. 02

    Architect

    We design the system with you: the electronics, the software stack, and the path between them, with an honest estimate of time, cost, and the team it takes.

  3. 03

    Design

    RF, analog, digital, and mixed-signal electronics; firmware through application software and cloud; mechanical engineering, with industrial design through our partners for form and enclosure.

  4. 04

    Prototype

    We build, bring up, and debug prototypes in the lab, and respin until the hardware is right.

  5. 05

    Qualify

    We design to the electrical, EMC, and regulatory standards the product has to meet, and build the test fixtures the production line will run.

  6. 06

    Transfer

    We hand the product to contract manufacturing, including tooling and molds, and the electrical and functional tests that run on every unit.

However you want to structure it.

Fixed Scope

Defined deliverables, technical milestones, and clear handoff points for well-specified programs.

Ongoing Partnership

Dedicated engineering capacity for product roadmaps that keep moving after the first release.

Startup Build Model

For startups

Selective cash and equity structures for early-stage teams building their first device, platform, or subsystem.

Representative work across all three models.

Browse our work

Representative engagements.

These examples show the shape of the work while project names and sensitive details stay confidential.

Medical hardware

Medical device electronics

Prototype through verification planning

  • Medical device
  • Electronics
  • Firmware

Problem: A portable diagnostic instrument needed custom power management, multi-channel sensing, and embedded processing on a regulated development path.

Contribution: Elfstone designed the power and sensing hardware, wrote the board firmware, and produced the verification evidence inputs for the IEC 62304 and 510(k) documentation set. The device reached design freeze with a complete verification evidence package.

Industrial IoT

Connected industrial monitoring

Architecture through field prototype

  • Industrial IoT
  • Edge compute
  • Cloud

Problem: Field equipment needed a ruggedized sensor node, edge compute, and telemetry that could operate reliably outside a controlled environment.

Contribution: Elfstone designed the device architecture, built the embedded sensor firmware and edge compute layer, and delivered the cloud telemetry path and engineering handoff documentation. The system reached first field pilot.

Cloud platform

Cloud and DevOps for connected products

Platform buildout and operations

  • AWS
  • CI/CD
  • Operations

Problem: A software-led product team needed device-aware CI/CD, cloud infrastructure, and OTA update delivery for their first connected product launch.

Contribution: Elfstone built the CI/CD pipeline, delivery infrastructure, and OTA update paths, then handed off to internal ops with documented runbooks. The platform handled first production device releases on schedule.

What are you building?

Tell us your stage, your architecture constraints, and where the hard questions are. We'll respond with engineering context.

Or email us at contact@elfstone.io