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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Precision analog circuits for biomedical signal acquisition — amplification, filtering, and conditioning engineered to extract clean, reliable data from even the most challenging physiological signals.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Sensor Integration
Integration of biomedical sensors — ECG, PPG, IMU, pressure, temperature, and biochemical — delivering clean, accurate signals ready for your device's processing pipeline.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
