Engineering  Medical Devices with Purpose

We help MedTech companies design and develop medical devices that combine technical excellence, reliability, and market readiness.

From early feasibility and system architecture to verification and validation, we support the full medical device development lifecycle with structured, regulatory-aware engineering under our ISO 13485-certified quality management system.

ISO:13485 Medical Device Design and Development

Trusted by 80+ companies

Our commitment to technological and medical innovation drives our excellence.

Full-stack medical device engineering, under one roof

Hardware

Medical-grade electronic design focused on safety, low power, and reliability. From system architecture to PCB design and prototyping.

Embedded Software

Reliable embedded firmware developed under IEC 62304 standards.
We focus on deterministic behavior, modular architectures, and built-in security.

Automated testing

Automated validation frameworks and Hardware-in-the-Loop testing that continuously verify device behavior, improving reliability and accelerating development.

Mobile

Secure companion apps connecting patients, clinicians, and medical devices through reliable communication, cloud integration, and intuitive interfaces.

Regulatory Support

We are ISO 13485 certified. We produce submission-ready DHF artifacts, verification reports, and regulatory documentation. Documentation is a core deliverable, not an afterthought.

Mechanical Development

Mechanical design and rapid prototyping for medical devices, from CAD to manufacturable parts, including AIMD enclosures, fixtures, accessories, and test tooling.

Our Primary Focus Areas

We have deep, hands-on experience across three device categories where engineering complexity, regulatory rigor, and clinical stakes are highest.

Neuromodulation

We have contributed to the development of implantable pulse generators and wearable neurostimulators across a range of neurostimulation therapies. Our hardware and firmware teams are fluent in the real-time, safety-critical constraints that define this space.

Cardiac Rhythm Management

We support active implantable and wearable cardiac devices where reliable sensing, low-power design, and fault-tolerant firmware are non-negotiable.

Wearable Monitors

From biosignal acquisition to wireless data offload, we develop wearable monitoring devices that meet the reliability and regulatory standards required for clinical use.

SUCCESS CASES

Our experience in action

Our portfolio showcases successful collaborations with leading medical device companies, helping bring innovative products from concept to market across implantable, wearable, and connected devices.

See all Case Studies ↗

MEDICAL DEVICES

Implantable Glucose Monitor

Hardware and firmware development for a first-in-human implantable glucose monitor with 3-year battery life.

MEDICAL DEVICES

OpenNerve

Full hardware design of an open-source implantable pulse generator, enabling accessible neuromodulation research worldwide.

MEDICAL DEVICES

AccelBand

Neuromodulation device aimed at treating neurogenic bowel dysfunction in individuals with spinal cord injury.

OUR SERVICES

Key AIMD experience

Our experience covers critical technologies for advanced medical devices, especially energy-constrained and implantable systems. We combine low-power design, secure connectivity, and safety-driven architectures to ensure reliable performance in clinical environments.

System Integration

From IPGs to programming devices and chargers, we bring every piece of your medical device ecosystem together — on spec, on time, and ready to scale.

HiL Testing

Hardware-in-the-Loop testing that verifies your embedded hardware and firmware in a controlled environment, using simulated clinical inputs and automated test systems to catch issues early.

PCBA Design

We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.

FW Development

From bare-metal C to Zephyr and FreeRTOS, we deliver the full firmware lifecycle — architecture, development, verification, and deployment — compliant with IEC 62304.

CI/CD Pipelines

We implement CI/CD pipelines that automate your full build, verification, and deployment cycle, boosting software reliability and accelerating your release cadence significantly.

Sensing Circuits

Precision analog circuits for biomedical signal acquisition — amplification, filtering, and conditioning engineered to extract clean, reliable data from even the most challenging physiological signals.

Ultra Low Power Design

We optimize hardware and firmware for ultra-low power operation, extending battery life and enabling always-on sensing in wearable and implantable medical devices.

Wireless Charging

We integrate inductive power transfer systems into rechargeable medical devices, enabling safe, cable-free charging for implantables and wearables with reliable, standards-compliant power delivery.

Stim Circuits Design

From signal generation to power output multiplexing, we design complete stimulation circuits built to your specs and compliant with ISO 14708 implantable device standards.

Bootloader & FOTA

Secure bootloaders and FOTA update mechanisms that keep your deployed devices current, safe, and resilient — without recalls, service visits, or downtime in the field.

Documentation Support

We prepare submission-ready technical documentation within a QMS aligned with ISO 13485 and FDA QMSR, including DHF artifacts, verification reports, and regulatory filing support.

Cybersecurity

We implement robust security architectures for connected medical devices, aligned with FDA cybersecurity guidance and modern standards to protect patient data and device integrity.

Risk Management

Structured risk management aligned with ISO 14971, covering hazard analysis, FMEA, and mitigation strategies to keep your device safe, compliant, and market-ready.

AFE Design

We design high-performance AFE circuits for ECG, EEG, EMG, and beyond, precisely matched to your sensors and clinical application requirements.

Wireless Connectivity

We develop wireless communication systems for medical devices, covering BLE, WiFi, LTE-M, and proprietary protocols, engineered for reliability, low power, and regulatory compliance.

Configuration & Change Control

Rigorous control of design changes, versions, and releases across the full product lifecycle, ensuring traceability, consistency, and audit readiness at every development milestone.

Documentation & Technical Files

Clear, complete, and submission-ready — we build the technical documentation that gets your device in front of regulators without delays or costly back-and-forth.

Automated Test fixtures

We build cost-efficient automated test fixtures that compress verification cycles, cut time-to-validation, and free your engineering team to focus on what matters most.

Design Control

A structured design and development process that ensures full traceability from requirements through verification, keeping your project audit-ready at every stage of development.

Tech Transfer

We transfer your full device design with complete documentation, source files, and hands-on technical guidance, empowering your team to develop and manufacture independently with confidence.

Sensor Integration

Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.

Wireless Charging

We integrate inductive power transfer systems into rechargeable medical devices, enabling safe, cable-free charging for implantables and wearables with reliable, standards-compliant power delivery.

System Integration

From IPGs to programming devices and chargers, we bring every piece of your medical device ecosystem together — on spec, on time, and ready to scale.

Wireless Connectivity

We develop wireless communication systems for medical devices, covering BLE, WiFi, LTE-M, and proprietary protocols, engineered for reliability, low power, and regulatory compliance.

CI/CD Pipelines

We implement CI/CD pipelines that automate your full build, verification, and deployment cycle, boosting software reliability and accelerating your release cadence significantly.

Configuration & Change Control

Rigorous control of design changes, versions, and releases across the full product lifecycle, ensuring traceability, consistency, and audit readiness at every development milestone.

Sensing Circuits

Stim Circuits Design

From signal generation to power output multiplexing, we design complete stimulation circuits built to your specs and compliant with ISO 14708 implantable device standards.

PCBA Design

We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.

Design Control

A structured design and development process that ensures full traceability from requirements through verification, keeping your project audit-ready at every stage of development.

Sensor Integration

Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.

Ultra Low Power Design

We optimize hardware and firmware for ultra-low power operation, extending battery life and enabling always-on sensing in wearable and implantable medical devices.

Risk Management

Structured risk management aligned with ISO 14971, covering hazard analysis, FMEA, and mitigation strategies to keep your device safe, compliant, and market-ready.

AFE Design

We design high-performance AFE circuits for ECG, EEG, EMG, and beyond, precisely matched to your sensors and clinical application requirements.

FW Development

From bare-metal C to Zephyr and FreeRTOS, we deliver the full firmware lifecycle — architecture, development, verification, and deployment — compliant with IEC 62304.

Automated Test fixtures

We build cost-efficient automated test fixtures that compress verification cycles, cut time-to-validation, and free your engineering team to focus on what matters most.

Tech Transfer

We transfer your full device design with complete documentation, source files, and hands-on technical guidance, empowering your team to develop and manufacture independently with confidence.

Bootloader & FOTA

Secure bootloaders and FOTA update mechanisms that keep your deployed devices current, safe, and resilient — without recalls, service visits, or downtime in the field.

Documentation & Technical Files

Clear, complete, and submission-ready — we build the technical documentation that gets your device in front of regulators without delays or costly back-and-forth.

HiL Testing

Hardware-in-the-Loop testing that verifies your embedded hardware and firmware in a controlled environment, using simulated clinical inputs and automated test systems to catch issues early.

Documentation Support

We prepare submission-ready technical documentation within a QMS aligned with ISO 13485 and FDA QMSR, including DHF artifacts, verification reports, and regulatory filing support.

Cybersecurity

We implement robust security architectures for connected medical devices, aligned with FDA cybersecurity guidance and modern standards to protect patient data and device integrity.

Cybersecurity

We implement robust security architectures for connected medical devices, aligned with FDA cybersecurity guidance and modern standards to protect patient data and device integrity.

Wireless Charging

We integrate inductive power transfer systems into rechargeable medical devices, enabling safe, cable-free charging for implantables and wearables with reliable, standards-compliant power delivery.

Documentation & Technical Files

Clear, complete, and submission-ready — we build the technical documentation that gets your device in front of regulators without delays or costly back-and-forth.

Wireless Connectivity

We develop wireless communication systems for medical devices, covering BLE, WiFi, LTE-M, and proprietary protocols, engineered for reliability, low power, and regulatory compliance.

Bootloader & FOTA

Secure bootloaders and FOTA update mechanisms that keep your deployed devices current, safe, and resilient — without recalls, service visits, or downtime in the field.

AFE Design

We design high-performance AFE circuits for ECG, EEG, EMG, and beyond, precisely matched to your sensors and clinical application requirements.

Ultra Low Power Design

We optimize hardware and firmware for ultra-low power operation, extending battery life and enabling always-on sensing in wearable and implantable medical devices.

Sensing Circuits

Configuration & Change Control

Rigorous control of design changes, versions, and releases across the full product lifecycle, ensuring traceability, consistency, and audit readiness at every development milestone.

PCBA Design

We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.

System Integration

From IPGs to programming devices and chargers, we bring every piece of your medical device ecosystem together — on spec, on time, and ready to scale.

FW Development

From bare-metal C to Zephyr and FreeRTOS, we deliver the full firmware lifecycle — architecture, development, verification, and deployment — compliant with IEC 62304.

HiL Testing

Hardware-in-the-Loop testing that verifies your embedded hardware and firmware in a controlled environment, using simulated clinical inputs and automated test systems to catch issues early.

CI/CD Pipelines

We implement CI/CD pipelines that automate your full build, verification, and deployment cycle, boosting software reliability and accelerating your release cadence significantly.

Documentation Support

We prepare submission-ready technical documentation within a QMS aligned with ISO 13485 and FDA QMSR, including DHF artifacts, verification reports, and regulatory filing support.

Sensor Integration

Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.

Tech Transfer

We transfer your full device design with complete documentation, source files, and hands-on technical guidance, empowering your team to develop and manufacture independently with confidence.

Risk Management

Structured risk management aligned with ISO 14971, covering hazard analysis, FMEA, and mitigation strategies to keep your device safe, compliant, and market-ready.

Design Control

A structured design and development process that ensures full traceability from requirements through verification, keeping your project audit-ready at every stage of development.

Automated Test fixtures

We build cost-efficient automated test fixtures that compress verification cycles, cut time-to-validation, and free your engineering team to focus on what matters most.

Stim Circuits Design

From signal generation to power output multiplexing, we design complete stimulation circuits built to your specs and compliant with ISO 14708 implantable device standards.

Sensing Circuits

Risk Management

Structured risk management aligned with ISO 14971, covering hazard analysis, FMEA, and mitigation strategies to keep your device safe, compliant, and market-ready.

AFE Design

We design high-performance AFE circuits for ECG, EEG, EMG, and beyond, precisely matched to your sensors and clinical application requirements.

Automated Test fixtures

We build cost-efficient automated test fixtures that compress verification cycles, cut time-to-validation, and free your engineering team to focus on what matters most.

Configuration & Change Control

Rigorous control of design changes, versions, and releases across the full product lifecycle, ensuring traceability, consistency, and audit readiness at every development milestone.

Ultra Low Power Design

We optimize hardware and firmware for ultra-low power operation, extending battery life and enabling always-on sensing in wearable and implantable medical devices.

Design Control

A structured design and development process that ensures full traceability from requirements through verification, keeping your project audit-ready at every stage of development.

PCBA Design

We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.

HiL Testing

Hardware-in-the-Loop testing that verifies your embedded hardware and firmware in a controlled environment, using simulated clinical inputs and automated test systems to catch issues early.

Tech Transfer

We transfer your full device design with complete documentation, source files, and hands-on technical guidance, empowering your team to develop and manufacture independently with confidence.

Wireless Connectivity

We develop wireless communication systems for medical devices, covering BLE, WiFi, LTE-M, and proprietary protocols, engineered for reliability, low power, and regulatory compliance.

Sensor Integration

Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.

Bootloader & FOTA

Secure bootloaders and FOTA update mechanisms that keep your deployed devices current, safe, and resilient — without recalls, service visits, or downtime in the field.

CI/CD Pipelines

We implement CI/CD pipelines that automate your full build, verification, and deployment cycle, boosting software reliability and accelerating your release cadence significantly.

Documentation & Technical Files

Clear, complete, and submission-ready — we build the technical documentation that gets your device in front of regulators without delays or costly back-and-forth.

System Integration

From IPGs to programming devices and chargers, we bring every piece of your medical device ecosystem together — on spec, on time, and ready to scale.

Wireless Charging

We integrate inductive power transfer systems into rechargeable medical devices, enabling safe, cable-free charging for implantables and wearables with reliable, standards-compliant power delivery.

FW Development

From bare-metal C to Zephyr and FreeRTOS, we deliver the full firmware lifecycle — architecture, development, verification, and deployment — compliant with IEC 62304.

Cybersecurity

We implement robust security architectures for connected medical devices, aligned with FDA cybersecurity guidance and modern standards to protect patient data and device integrity.

Documentation Support

We prepare submission-ready technical documentation within a QMS aligned with ISO 13485 and FDA QMSR, including DHF artifacts, verification reports, and regulatory filing support.

Stim Circuits Design

From signal generation to power output multiplexing, we design complete stimulation circuits built to your specs and compliant with ISO 14708 implantable device standards.

Design Control

A structured design and development process that ensures full traceability from requirements through verification, keeping your project audit-ready at every stage of development.

Documentation & Technical Files

Clear, complete, and submission-ready — we build the technical documentation that gets your device in front of regulators without delays or costly back-and-forth.

Sensing Circuits

Cybersecurity

We implement robust security architectures for connected medical devices, aligned with FDA cybersecurity guidance and modern standards to protect patient data and device integrity.

Bootloader & FOTA

Secure bootloaders and FOTA update mechanisms that keep your deployed devices current, safe, and resilient — without recalls, service visits, or downtime in the field.

Sensor Integration

Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.

AFE Design

We design high-performance AFE circuits for ECG, EEG, EMG, and beyond, precisely matched to your sensors and clinical application requirements.

Risk Management

Structured risk management aligned with ISO 14971, covering hazard analysis, FMEA, and mitigation strategies to keep your device safe, compliant, and market-ready.

Wireless Charging

We integrate inductive power transfer systems into rechargeable medical devices, enabling safe, cable-free charging for implantables and wearables with reliable, standards-compliant power delivery.

Tech Transfer

We transfer your full device design with complete documentation, source files, and hands-on technical guidance, empowering your team to develop and manufacture independently with confidence.

Wireless Connectivity

We develop wireless communication systems for medical devices, covering BLE, WiFi, LTE-M, and proprietary protocols, engineered for reliability, low power, and regulatory compliance.

Stim Circuits Design

From signal generation to power output multiplexing, we design complete stimulation circuits built to your specs and compliant with ISO 14708 implantable device standards.

Ultra Low Power Design

We optimize hardware and firmware for ultra-low power operation, extending battery life and enabling always-on sensing in wearable and implantable medical devices.

Automated Test fixtures

We build cost-efficient automated test fixtures that compress verification cycles, cut time-to-validation, and free your engineering team to focus on what matters most.

PCBA Design

We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.

System Integration

From IPGs to programming devices and chargers, we bring every piece of your medical device ecosystem together — on spec, on time, and ready to scale.

Documentation Support

We prepare submission-ready technical documentation within a QMS aligned with ISO 13485 and FDA QMSR, including DHF artifacts, verification reports, and regulatory filing support.

Configuration & Change Control

Rigorous control of design changes, versions, and releases across the full product lifecycle, ensuring traceability, consistency, and audit readiness at every development milestone.

CI/CD Pipelines

We implement CI/CD pipelines that automate your full build, verification, and deployment cycle, boosting software reliability and accelerating your release cadence significantly.

HiL Testing

Hardware-in-the-Loop testing that verifies your embedded hardware and firmware in a controlled environment, using simulated clinical inputs and automated test systems to catch issues early.

FW Development

From bare-metal C to Zephyr and FreeRTOS, we deliver the full firmware lifecycle — architecture, development, verification, and deployment — compliant with IEC 62304.

HiL Testing

Hardware-in-the-Loop testing that verifies your embedded hardware and firmware in a controlled environment, using simulated clinical inputs and automated test systems to catch issues early.

Wireless Charging

We integrate inductive power transfer systems into rechargeable medical devices, enabling safe, cable-free charging for implantables and wearables with reliable, standards-compliant power delivery.

Sensor Integration

Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.

PCBA Design

We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.

Documentation Support

We prepare submission-ready technical documentation within a QMS aligned with ISO 13485 and FDA QMSR, including DHF artifacts, verification reports, and regulatory filing support.

System Integration

From IPGs to programming devices and chargers, we bring every piece of your medical device ecosystem together — on spec, on time, and ready to scale.

Documentation & Technical Files

Clear, complete, and submission-ready — we build the technical documentation that gets your device in front of regulators without delays or costly back-and-forth.

Design Control

A structured design and development process that ensures full traceability from requirements through verification, keeping your project audit-ready at every stage of development.

Tech Transfer

We transfer your full device design with complete documentation, source files, and hands-on technical guidance, empowering your team to develop and manufacture independently with confidence.

Risk Management

Structured risk management aligned with ISO 14971, covering hazard analysis, FMEA, and mitigation strategies to keep your device safe, compliant, and market-ready.

Automated Test fixtures

We build cost-efficient automated test fixtures that compress verification cycles, cut time-to-validation, and free your engineering team to focus on what matters most.

Bootloader & FOTA

Secure bootloaders and FOTA update mechanisms that keep your deployed devices current, safe, and resilient — without recalls, service visits, or downtime in the field.

Configuration & Change Control

Rigorous control of design changes, versions, and releases across the full product lifecycle, ensuring traceability, consistency, and audit readiness at every development milestone.

FW Development

From bare-metal C to Zephyr and FreeRTOS, we deliver the full firmware lifecycle — architecture, development, verification, and deployment — compliant with IEC 62304.

Stim Circuits Design

From signal generation to power output multiplexing, we design complete stimulation circuits built to your specs and compliant with ISO 14708 implantable device standards.

AFE Design

We design high-performance AFE circuits for ECG, EEG, EMG, and beyond, precisely matched to your sensors and clinical application requirements.

Ultra Low Power Design

We optimize hardware and firmware for ultra-low power operation, extending battery life and enabling always-on sensing in wearable and implantable medical devices.

CI/CD Pipelines

We implement CI/CD pipelines that automate your full build, verification, and deployment cycle, boosting software reliability and accelerating your release cadence significantly.

Sensing Circuits

Cybersecurity

We implement robust security architectures for connected medical devices, aligned with FDA cybersecurity guidance and modern standards to protect patient data and device integrity.

Wireless Connectivity

We develop wireless communication systems for medical devices, covering BLE, WiFi, LTE-M, and proprietary protocols, engineered for reliability, low power, and regulatory compliance.