Reinventing Medical Devices with Purpose

We partner with medical device companies to design and develop medical devices that combine technical excellence, reliability, and market readiness, while supporting the regulatory documentation needed to achieve their goals.

From early feasibility and system architecture to verification and validation, we support the full medical device development lifecycle with structured, regulatory-aware engineering.

TURNKEY SERVICES

We take full ownership of medical device development programs, delivering end-to-end solutions across hardware, firmware, embedded software, and testing.

COLLABORATIVE WORK

We integrate with your internal engineering and quality teams, contributing specialized expertise in safety-critical embedded systems and scalable development capacity.

Our commitment to technological and medical innovation drives our excellence.

We can
help you with

Our work extends from early feasibility through commercialization, including regulatory support and submission-ready documentation packages.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

Sensor Integration

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

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.

PCBA Design

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

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.

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.

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.

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.

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 & 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.

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.

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.

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.

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.

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.

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.

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.

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.

Sensor Integration

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

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.

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.

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.

AFE Design

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

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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

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

AFE Design

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

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.

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.

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.

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.

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.

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.

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.

PCBA Design

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

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.

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.

PCBA Design

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

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.

AFE Design

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

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.

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 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.

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.

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.

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.

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.

FMD is 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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