We Build Complex Medical Devices Fast

From idea to manufacturing in 6–12 months. Not consultants. Not advisors — an engineering team of 62 working under an ISO 13485:2016 certified quality system, with 220 devices developed. If it doesn’t work, we fix it at our cost.

Ready to turn your idea into revenue? Let’s talk

or request development

5.0

“Spot-on understanding of healthtech combined with reliable delivery.”

Engineering

Product Design

5.0

“Consistently impressed us with their proactive and innovative thinking.”

Engineering

Product Design

Contract Manufacturing

5.0

“They find elegant technical solutions without overcomplicating things – exactly what we needed.”

Hardware Design

Engineering

5.0

“Their proactive approach to problem-solving and their commitment to understanding our vision made them stand out”

Engineering

Product Design

Our Services

Full-cycle hardware and medical device engineering — from first sketch to serial production, all in-house.

Research & Discovery

Competitive landscape survey

Ethnographic research

Technology review

Empirical data collection

Literature and patent review

Concept Exploration

Idea generation

Concept development

Refined/precise sketching

Thumbnail sketching

FDA Consulting

Detailed colour renderings

Marketing and branding support

Prototype Design

Creation of POC

Mechanical verification

Schematic and PCB design

Rapid prototyping

Field testing

Firmware and software authoring

Production Design

Recommended manufacturing tools and processes

Supply chain validation

Materials and color selection

Linux and Android Porting and Optimization

Production-ready 3D data 2D drawing package

Product Supervision

Vendor assessment and qualification

Internal and external quality audits

Production quoting

ISO compliant CAPA and RMA documentation handling

Onshore and offshore manufacturing support

Regulatory Pathway Analysis And Guidance

FDA Regulatory Strategy

FDA Compliance Consulting

Property Protection

Consultation for Intellectual Property

Labeling and Marketing Compliance

Production Supervision

We Make Sure Your Device Can Be Built
Most prototypes fail in production. We’ve helped 220 projects avoid this trap and save serious money. How? We design with manufacturing in mind from day one.

Small fixes early on save big money later:

Average savings: $100,000 per prototype
Months saved: 3-6 months of fixes and delays
Proven track record: 220 devices developed

Let’s talk for 45 minutes. You’ll see exactly how we can help you avoid costly mistakes.

Industries We Serve

Robotics

We specialize in complex surgical robotics and other precision medical equipment that demands meticulous design and seamless integration. If it’s for the operating room, we’ve been there and done that.

Orthopedics

High-precision orthopedic devices. With a dedicated cleanroom, we ensure your device is built to exacting standards, down to the micrometer.

Wearables

From medical-grade health monitors to consumer wellness devices, we build wearables that go beyond trendy to deliver reliable performance and user-friendly designs.

FDA Class I–III Devices

Our team has proven expertise across FDA classifications, from Class I and II devices to the intense regulatory demands of Class III equipment.

Your product requires more than just functionality — it demands expertise across every level. We’re here to make that happen!

220 projects in 11 years. Here’s the breakdown.

Projects in 11 years

Medical devices

0 +

Engineers in-house

Certified QMS

ISO 0

plus 60+ non-medical hardware projects behind them

Our Works

Explore our works to see how we turn ideas into exceptional experiences and solutions.

Medical

Vexar

Smart, dose-controlled prescription medication delivery system seamlessly connecting the drug supply chain with the goal of improving safety, compliance, and prescription adherence.

Orthopedics

IoT

Rombot

A new revolutionary device empowering at-home patient recovery and remote monitoring for effective managed care.

EEG

EEG Monitor

Revolutionary wireless EEG monitoring platform that captures micro-voltage brain signals through a proprietary noise-filtering system, enabling real-time data transmission and analysis for enhanced clinical decision-making.

Orthopedics

Engineering

Smart Crutch Tips

Advanced rehabilitation monitoring system with integrated strain gauges and real-time feedback technology, transforming standard crutches into precision recovery tools for optimal weight-bearing control and faster patient rehabilitation.

Orthopedics

Engineering

Medical

Rapid Cooling Device

Portable medical system with precision temperature control algorithm maintaining 2°F accuracy, revolutionizing post-operative care through smart thermal exchange technology for optimal tissue healing and patient comfort.

Colonoscope

Snake AI Colonoscopy

AI-powered robotic colonoscopy system with patented movement technology that combines smart navigation and disposable components to revolutionize cancer screening accessibility and patient comfort.

If it doesn't work, we fix it at our cost.

We take full engineering responsibility for what we build. If a device we engineered fails to perform to the agreed specification, we make it right at our expense. That’s been our policy for 11 years — affordable to us only because it’s rarely needed.

About Us

In 2015, we started as a smart home IoT startup, then evolved into an R&D shop. Same core team, now over a decade strong. We’re a highly creative, deeply technical company that fuses research and analytics with mind-blowing ideas.

Our R&D office is based in Ukraine, and since the war began, our focus sharpened — we only take on projects that genuinely matter. If you’re just looking to pump out a mediocre prototype to chase your next funding round, we’re not a match.

Today, our team of 62 specialists has brought 220 projects to life.