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.
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.
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Embedded Software
Reliable embedded firmware developed under IEC 62304 standards.
We focus on deterministic behavior, modular architectures, and built-in security.
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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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
PCBA Design
We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
PCBA Design
We design high-reliability PCBs optimized for performance, manufacturability, and full compliance with medical electrical equipment standards, including IEC 60601-1.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 & 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.
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.
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.
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.
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.
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 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.
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.
Sensor Integration
Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.
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.
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.
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.
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.
Sensor Integration
Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
AFE Design
We design high-performance AFE circuits for ECG, EEG, EMG, and beyond, precisely matched to your sensors and clinical application requirements.
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.
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