We bring complex electromechanical medical devices to life by combining embedded
firmware, custom PCB design, and systems engineering to streamline development, align
with regulatory requirements, and accelerate time to market.
We build electromechanical
solutions to enable healthcare
innovation.
Systems Architecture & Integration
Our systems engineers lead the development of complex electromechanical medical devices by managing product architecture, requirements definition, and seamless integration of software and hardware to deliver a unified regulatory-compliant product.
We drive cross-functional alignment throughout the full product development lifecycle—from early concept through market release.
We have broad experience across device types including therapeutics, diagnostics, robotics, electrosurgical instruments, digital health, patient-monitoring, wearables, infusion, and more.
Hardware Design
Our electrical engineering team brings deep expertise in the design and development of custom printed circuit board assemblies (PCBAs) for medical devices with a focus on electrical safety, reliability, and supply-chain availability.
We specialize in electrical design with a focus on long lifecycle support, cost-effective manufacturing, and compliance with IEC 60601 standards.
Our designs can incorporate advanced sensing technologies for parameters such as temperature, pressure, proximity, touch, gas, optical signals, physiological metrics, ultrasonic, flow, and motion.
Software Development
From enabling accurate drug delivery to powering critical diagnostic systems, our software is engineered for reliability, consistency, and compliance in regulated medical environments.
Our team specializes in IEC 62304-compliant software development, integrating robust design controls, complete documentation, and full traceability throughout development.
We have deep expertise in C/C++ programming, RISC and ARM-based microcontroller architectures, and low-level device drivers.
Prototyping & Testing
Our team builds and tests sophisticated electromechanical medical devices, from early-stage prototypes to fully functional systems.
We combine off-the-shelf components and custom-designed circuit board assemblies to prototype products for functional testing and validation.
Our hands-on bench testing approach allows us to evaluate device performance and identify electrical safety compliance challenges helping to de-risk the path to commercialization.
Regulatory
Expert guidance
through every stage
of development
Our team supports clients with the regulatory planning, preparation, and interaction needed to bring products to market and maintain long-term compliance. Our support includes preparing documentation, managing regulatory communications, and supporting submission processes for medical devices and combination products.
Regulatory Filings & Interactions
We support 510(k) submissions, CE Technical Files, FDA Q-submissions, and preparation for meetings related to IND and NDA pathways.
Medical Device Development
We help devices obtain regulatory approval faster by creating strong strategies that align development with appropriate regulatory pathways across global markets.
Combination Product Development
Our streamlined quality system and drug handling capabilities accelerate development for drug delivery devices and combination products.
Talk to an Expert
Gilero combines engineering expertise, advanced manufacturing capabilities, and regulatory support from concept to commercialization to bring your ideas to life. Ready to turn your vision into reality? Talk to an expert today.