Design History File and Standards Documentation
The engineering side of a regulatory submission, built together with the device instead of reconstructed at the end. We prepare the design history file, design inputs and outputs, ISO 14971 risk management inputs including fault tree analysis, verification plans and reports, test software, and the...
Neurotechnology and EEG Device Development
Engineering for neurotechnology: EEG acquisition boards, a wireless EEG monitoring platform, a wearable controller for a sensory-restoration neural implant, and neuromuscular stimulators. Micro-volt brain signals need low-noise analog front ends, careful grounding and shielding, and filtering that...
Respiratory and Critical Care Device Engineering
Engineering for life-support and critical care equipment. Our reference project is a portable battery-powered ventilator built from ten boards: respiratory control, oxygen and air mixing, capnography, battery management and user interface. The boards were split by hazard boundary, and the...
Engineering for surgical robotics and operating room equipment, where precision, integration and a clean risk file matter as much as the mechanics. Our work includes electronics, firmware and an NFC reader for a multi-specialty surgical robot, an AI-powered robotic colonoscopy system with...
Medical Device Development for Startups
For founders who need a first device to show investors, run a clinical study or get to a 510(k). We start with a discovery phase that turns the idea into requirements, an architecture and a phase plan with hours, so the budget and timeline become firm numbers in the contract. Then we answer the...
Design for Manufacturing and Design Transfer
We make sure your device can be built. Design for manufacturing and transfer to your contract manufacturer in the US, Europe or Asia: bill of materials with second sources for critical parts, test strategy, test points and end-of-line fixtures, work instructions, production-ready 3D data and a 2D...
Orthopedic and Rehabilitation Device Development
Engineering for orthopedic and rehabilitation devices: load-sensing crutches, range-of-motion and gait monitors, post-operative therapy devices, powered rehabilitation equipment, fixation tools and instruments. Mechanical design with finite element and stress analysis, sensors and electronics,...
Wearable Medical Device Development
Engineering for medical and wellness wearables: wrist monitors with cuff blood pressure, skin-worn patches, glucose monitoring patches, knee and gait monitors, neuromuscular stimulators and remote patient monitoring devices. We handle low-power electronics, sensor front ends (ECG, SpO2, IMU), BLE...
Medical Device Prototyping and Pilot Batches
Prototypes that answer the riskiest question first, then look and behave like the production device. Digital prototypes and simulation, 3D-printed and machined parts, board spins, test stands and robotic test rigs, functional prototypes and a golden sample: the pre-certification unit that fully...
Firmware and embedded software for medical devices on STM32, nRF and ESP32 microcontrollers with FreeRTOS or Zephyr, and Yocto Linux on i.MX processors. BLE stacks, update mechanisms, device drivers, signal processing, test software, and Linux or Android porting and optimization. All work follows...
Medical Electronics and PCB Design
Electronics design for medical devices: low-noise analog front ends for ECG and EEG, sensor interfaces, battery, charging and power paths, BLE, Wi-Fi and cellular radios, defibrillation and ESD protection, multilayer and rigid-flex boards. Schematics and layout are built with IEC 60601-1 electrical...
Full-cycle medical device engineering from the first requirement to a design your contract manufacturer can build. One team covers discovery, electronics, firmware, mechanics, prototypes and design transfer, working under an ISO 13485:2016 certified quality system. 220 medical devices developed...
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