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.

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, we build hardware ready for regulated environments.

Embedded Software

Reliable embedded firmware developed under IEC 62304 standards.
We focus on deterministic behavior, modular architectures, and built-in security to support long-term product evolution.

Automatic 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

Submission-ready DHF artifacts, verification reports, and regulatory filing. Aligned with ISO 13485 and FDA QMSR. Documentation is a deliverable, not an afterthought.

Mechanical Development

Rapid iteration of mechanical components for medical devices, from CAD to manufacturable AIMD enclosures, headers, fixtures, accessories, and test tooling, using materials and finishes suited for sterilization and clinical environments.

We have vast experience in the development of neuromodulation systems:

We have worked on multiple Implantable Pulse Generators for different neurostimulation therapies and novel wearable neurostimulators for bioelectronic medicine.
Leveraging our firmware and hardware experience for real-time critical embedded systems, we have successfully contributed to advanced neuromodulation solutions that redefine patient care.

Probes connected to an orange circuit board for electronic testing or measurement.

SUCCESS CASES

Our experience in action

Our portfolio showcases successful collaborations with leading robotics innovators, particularly businesses with ambitious timelines across diverse industries like agriculture, retail, and logistics.

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.

Sensor Integration

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Cybesecurity

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

AFE Design

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

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.

PCBA Design

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

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.

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.

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.

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.

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.

AFE Design

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

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 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.

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.

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.

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.

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.

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.

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.

Cybesecurity

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

Sensing Circuits

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.

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.

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.

Sensing Circuits

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.

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.

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.

Sensor Integration

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

Cybesecurity

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

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.

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.

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.

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.

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.

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.

PCBA Design

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

AFE Design

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

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.

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.

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.

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.

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.

Sensor Integration

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

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.

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.

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.

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.

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.

PCBA Design

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

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.

Cybesecurity

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

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.

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.

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.

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.

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.

AFE Design

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

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.

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

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.

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.

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.

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.

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.

AFE Design

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

Cybesecurity

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

Sensing Circuits

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.

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.

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.

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.

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.

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 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.

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.

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.

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 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.

Sensing Circuits

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.

Sensor Integration

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

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.

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.

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.

AFE Design

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

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.

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.

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.

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.

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.

Cybesecurity

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

PCBA Design

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

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.

We are committed to:

Innovative Excellence

Delivering innovative, safe, secure, and effective medical devices that meet customer expectations.

Regulatory Commitment

Ensuring compliance with regulatory requirements while continuously improving quality and safety.

Proactive Risk Management

Adhering to risk management practices throughout the lifecycle of each medical device.

Transparent Collaboration

Maintaining open communication with all stakeholders to foster collaboration and transparency.

Let’s build something meaningful together

At Focus, we work closely with our clients to turn complex problems into reliable, real-world solutions.

How Can We Help?

You have an idea and want to turn it into a real product.

You’re facing a complex technical challenge and need expert support.

You’re looking for a long-term engineering partner, not just a vendor.

You want to extend your team with experienced engineers.

Thank you!

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Engineering Medical Devices with Purpose

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

Full-stack medical device engineering, under one roof

We have vast experience in the development of neuromodulation systems:

Our experience in action

Key AIMD experience

We are committed to:

Let’s build something meaningful together

How Can We Help?

Engineering  Medical Devices with Purpose