Compliance-Ready Embedded Firmware for Medical Devices

Reduce time-to-market, streamline development, and deliver reliable, high-quality firmware with Dojo Five.

Why Partner with Dojo Five for Medical Device Firmware?

Bringing a medical device to market requires speed, precision, and reliable engineering. Dojo Five helps you scale quickly with flexible engagement models, proven firmware processes, and modern tools tailored for medical device firmware development. We accelerate your time-to-market and deliver high-quality, secure firmware—so you can focus on innovation, not infrastructure.

Are These Firmware Challenges Delaying Your Med Device Launch?

Is your firmware process built for the complexity of medical devices?

Delivering safe, high-quality products requires structure, traceability, and a rock-solid development workflow—is your team set up for success?

Is your firmware development process still manual and outdated?

Legacy tooling and tribal knowledge can slow you down and introduce errors—what’s your plan to modernize?

Are long development cycles putting your product launch at risk?

Compliance hurdles and fragmented tooling often delay go-to-market timelines—how much is that costing you?

Do you struggle with traceability from requirements to test cases?

Full traceability is essential for audits and product safety—can your team prove it end-to-end?

Is your medical firmware secure and built for reliability?

Security and fault tolerance aren't optional—how confident are you in your firmware’s resilience?

Is your team stretched thin trying to do it all?

From architecture to testing to delivery, firmware development demands specialized skills—does your team have the bandwidth to scale without burning out?

See What Our Customers Have To Say

The Dojo Five team, as well as their processes, helped to simplify our project from beginning to end. Consistent communication played a major role in the success of our project. Their experienced team of experts helped us save both time and expenses throughout the build process. Quick onboarding and no long-term commitment saved us from needing to hire an internal resource.”

Jason Sutor

Director of External Sales, Invicta Medical

Modernize Your Medical Device Firmware with Confidence

At Dojo Five, we help medtech teams replace outdated workflows with modern tooling, automation, and compliance-ready frameworks. From secure CI/CD pipelines to traceability and legacy system upgrades, our approach accelerates development, reduces risk, and supports regulatory success—without sacrificing safety or quality.

Compliance-Ready Frameworks

We architect firmware solutions with IEC 62304 and FDA expectations in mind. Our development workflows include baked-in traceability, version control, and documentation best practices from day one.

Automated CI/CD Pipelines

We set up automated testing, build, and deployment pipelines tailored for embedded firmware—reducing manual errors and accelerating validation cycles.

Modern Tooling and Architecture

From RTOS decisions to modular code architecture, we help your team build scalable, maintainable firmware using industry best practices.

Traceability & Documentation

We help teams implement tooling and workflows that maintain clear traceability between requirements, code, and tests—essential for audits and certification.

Secure Development Lifecycle Support

Our secure build environments and static analysis tooling help ensure your firmware is robust, reliable, and protected against vulnerabilities.

Legacy System Modernization

Need to upgrade or validate legacy codebases? We help teams refactor old systems for modern compliance, speed, and maintainability.

Companies We've Delighted

See How Dojo Five Helped Restera Modernize Their Embedded Development Process

Restera, a medtech startup developing a wearable treatment for obstructive sleep apnea, faced strict regulatory deadlines with limited internal resources. By partnering with Dojo Five, they leveraged deep expertise in Nordic BLE and medical device compliance to complete critical firmware ahead of their clinical trials. This collaboration enabled Restera to accelerate development, ensure compliance, and stay on track for bringing their innovative solution to patients.

Principles and Best Practices for Medical Device Firmware Development

Our white paper examines the core principles of IEC 62304, outlines key challenges in firmware development, and presents proven compliance approaches. We conclude by showing how DojoFive’s modern development practices and automated frameworks can help medical device manufacturers meet these challenges.

Accelerating Medical Device Development

Accelerate your medical device software development by streamlining workflows within existing regulatory standards. In this blog, we break down the key industry requirements and share practical strategies to boost efficiency and shave time off your project timelines.

Frequently Asked Questions

What types of Medical Device firmware solutions and services does Dojo Five provide?

Dojo Five provides embedded firmware development, modernization, DevOps automation, and compliance-ready solutions tailored to medical devices. We help teams meet IEC 62304 standards, streamline development, and build secure, high-quality firmware faster.

What technologies does Dojo Five use for their med device embedded projects?

Dojo Five uses C, C++, Rust, Python, and modern tools like Docker, Git, and CI/CD pipelines. We support RTOS-based systems, custom bootloaders, secure firmware updates, and work with popular MCUs like Nordic, STM32, and NXP.

What's the best way to get started with a med device firmware project?

The best way to get started is to schedule a free consultation with our team. We’ll assess your project needs, compliance goals, and development timeline to recommend the right path forward.