Services

Inside the Machine

Hardware design, precision manufacturing, and the craft of computing for medical systems that cannot fail.

Treatments

Schematic capture, PCB layout, and FPGA firmware for medical devices engineered from transistor to enclosure, validated for IEC 60601.

SMT lines, precision CNC, and conformal coating built around low-volume medical runs with full lot traceability and ISO 13485 controls.

Box build, cable harness, and sub-system integration performed in ESD-safe cells by IPC-A-610 trained technicians on medical product lines.

ICT, flying probe, burn-in, and EMC pre-compliance chambers delivering documented test protocols aligned with FDA and CE submission needs.

Design for manufacturability, regulatory pathway guidance, and supply chain hardening from concept through post-market surveillance planning.

Component obsolescence monitoring, revision-controlled rework, and field return analysis keeping deployed medical hardware certified and supported.

Requirements intake, regulatory mapping, and feasibility study translating clinical intent into engineering specifications and risk files.

Circuit, mechanical, and firmware development with weekly design reviews, DFM feedback, and verified prototypes before tooling commits.

Pilot run on dedicated lines, traceability captured per unit, with controlled travelers and approved supplier list for every component.

Functional, environmental, and EMC qualification, full design history file packaged for your regulatory submission and production transfer.

Every step from quote to shipment runs inside a certified quality management system audited for medical device manufacturing.

Component lot, process, and operator records retained per device serial, ready for FDA inspection and field action analysis.

Assembly workmanship held to the highest IPC standard, with certified inspectors reviewing every medical build before release.

Sensitive assemblies built under controlled particulate and humidity conditions to protect optics, sensors, and bare silicon.

Logic Computer House took our diagnostic prototype from breadboard to FDA submission in fourteen months without a single field failure in pilot.

Dr. Helena Voss — VP Engineering, Cardionics

Their DFM pass cut our BOM cost eighteen percent and eliminated a thermal issue we had chased for two quarters. True manufacturing partners.

Marcus Imai — Director of Hardware, Nimbus Med

From Class III implantables to bedside monitors, our atelier builds medical hardware the way it deserves to be built.