HealthTech & medical device engineering

Medical device partners, not a generic software vendor

Get a medical software assessment

We review your architecture and your traceability before an auditor does.

Clean-room corridor lined with glass partitions
Gloved hands operating a tablet in a clinical setting
  • IEC 62304 lifecycle

  • Sensor-to-record pipelines

  • Audit-ready traceability

Engineer working on a circuit board under a bench lamp with fine tools
Why regulated builds fail late

Tired of discovering at audit that your software isn't traceable?

Clinical software written first and documented later turns submission into a six-month refactor, long after the engineering is done.

01

Safety classification before code

We set the software safety class and the IEC 62304 lifecycle up front, so the process fits the device instead of being retrofitted around finished code.

02

Traceability as a build artefact

Requirements, risk controls and tests linked as the work happens, so the technical file assembles itself rather than being reconstructed from memory.

03

A knowledge-transfer plan from day one

Modular, documented code and a clear path to bring the work in-house when you're ready, no lock-in.

Where we work

One engineering team, every regulated build

The sectors where our firmware, apps and clinical data engineering already run in production.

  • Scuba & Marine

    Dive physiology and decompression data inside certified hardware

  • Defence & Tactical

    Field medical devices built for ruggedized deployment

  • Telco Off-grid

    Connected devices that keep logging when the link drops

  • Healthcare Tracking

    RTLS and IoT firmware for hospital-grade asset tracking

  • Wearable & Access control

    Patient-worn sensors and biometric access to clinical data

  • AI & Data pipeline

    Clinical data pipelines with provenance you can audit

Partnership

Innovating challenging environments

The network of brands and specialists Endcode builds extreme-environment technology with.

  • SEAC SUB

    SEAC SUB

    Dive equipment

  • SMARTY

    SMARTY

    5G connectivity

  • INSTRUCTOR ZERO

    INSTRUCTOR ZERO

    Survival & expeditions

  • GATE ENTERPRISE

    GATE ENTERPRISE

    Airsoft equipment

  • NIKK SAKK

    NIKK SAKK

    AEG customization

  • AROX

    AROX

    Hardware partner

For the engineer who has to sign off on this

Technical specifications

Architectural detail for your engineering team.

Oceanic +

Oceanic+ turns Apple Watch Ultra into a fully certified dive computer — safety-critical data, a certification path, and validation in the field rather than on a bench.

Oceanic+ launch, Apple Watch Ultra — Nov. 2022

Scuba diver underwater wearing an Apple Watch Ultra running Oceanic+

How do we know the technical file will hold up at audit?

Every engagement ships the traceability matrix, risk controls and test evidence as build artefacts rather than a document written at the end — plus a knowledge-transfer plan to your internal team, written into the contract, not promised verbally.

Close-up of microscope objective lenses
Intravenous drip bottle and needle in high contrast
Row of medical instruments on a clinical rack

Get a technical assessment before you commit budget

One conversation with our engineers, no sales pitch, just a clear read on where your regulatory and architectural risk actually sits.
Name*
Business email*
Privacy Policy