Developing MDR-Aligned Medical Software for a MedTech Giant

MedTech Leading Manufacturer Delivering Critical Infrastructure for Healthcare Settings

A leading MedTech manufacturer, known for its high-quality sterilisation and disinfection devices, had developed its systems on legacy embedded Software. Over time, the lack of structured medical software development made these systems difficult to scale, slow to adapt to new features, and risky to maintain.

The company aimed to future-proof its product line by modernising the firmware to meet growing regulatory and technical requirements including MDR alignment, touchscreen upgrades, and improved connectivity. However, their in-house engineering resources lacked the capacity and structure to manage a complete transition while continuing day-to-day operations.

They were faced with outdated architecture, growing certification complexity, and a pressure to deliver product innovations.

Outdated Medical Software Blocking Development and Innovation

The embedded software running on the client’s devices had grown over years into a tangled, unstructured codebase. This complexity made even small changes difficult and time-consuming to implement. As a result, new features such as capacitive touchscreen support, modern audio feedback, or integration with external systems were constantly delayed or unprioritised.

Certification and documentation efforts were also becoming inefficient. The lack of clear module ownership, missing unit tests, and minimal CI/CD automation introduced unnecessary risk during audits and MDR-related updates. Regulatory teams had to work around limitations instead of building on top of a compliant foundation.

The current architecture also limited the hardware team’s ambitions. Any upgrade to processors, peripherals or connectivity required significant manual rework, delaying critical improvements across the product line.

Scaling Product Innovation Was Impossible Without a Modern Software Core

With a fragmented codebase and outdated processes, the manufacturer couldn’t move fast on innovation and risked falling behind competitors. Each change introduced new bugs, validation cycles were long and unpredictable, and internal teams lacked confidence in the system’s stability.

There was no established CI/CD process, no systematic unit testing, and no unified approach to risk analysis or documentation, all essential for regulatory compliance under MDR. Adding new features like upgraded touchscreens, audio alerts, or cloud connectivity meant reworking brittle systems without a safety net.

Internally, engineers were stretched thin. A structured medical software development approach was missing, which slowed feature delivery and regulatory updates.

They Needed a MedTech Partner to Modernise Legacy Firmware for the Future

The company understood that modernising embedded software in a regulated medical device environment requires deep technical capacity, structured processes, and regulatory awareness.

They reached out to us for support in transitioning to a more maintainable and scalable software setup. Their internal team continued to handle day-to-day operations, while we were tasked with setting up a robust medical software development process and laying the foundation for MDR-aligned development.

We started by aligning workflows, defining documentation standards, and addressing the most critical areas of the codebase first.

Medical Software Development: From Concept to Maintainable Firmware

Once the roadmap was defined, we started with a full code audit and repository restructuring. The aim was to separate subsystems, remove unused logic, and improve readability to make future changes safer and faster. This step also allowed us to identify dependencies and functions that required the most attention during refactoring.

We migrated the build system to CMake and set up a new tool chain based on the latest ARM GCC compiler. This created a stable foundation for automated builds and future hardware support. It also ensured that the codebase could be compiled consistently and integrated smoothly with the new CI pipeline.

With the infrastructure in place, we began refactoring the highest‑risk modules, splitting large files into smaller components and preparing them for unit testing and CI integration.

Real-Time Testing and Risk Reduction with CI/CD: Developing a Reliable Medical Software

After the core refactoring steps, we implemented a CI/CD pipeline to automate builds, run unit tests, and generate code coverage reports. This ensured that every change could be validated quickly and consistently, while also improving traceability for certification.

Unit testing was introduced using CppUTest, focusing on the most critical and complex modules first. We reached 50–60% coverage for high‑risk areas, reducing the chance of regressions during future updates and making future feature integration more reliable.

The combination of automated testing and modularised code allowed the client to adopt a safer, more predictable development process.

Preparing & Developing Medical Software for Future Hardware and Feature Upgrades

With a stable and testable codebase in place, we prepared the firmware for upcoming hardware changes. These included migration to a new processor, support for a larger touchscreen, and improvements to audio feedback and communication protocols. The goal was to enable these upgrades without the need for extensive rework in future development cycles.

Low-level drivers for I2C, serial communication, and storage were updated and moved behind a hardware abstraction layer. This reduced dependencies and made it easier to adapt the firmware to future hardware variants without major rewrites. It also ensured that the new hardware components could be integrated with minimal risk to existing functionalities.

These steps ensured that the client can expand device capabilities confidently while keeping development costs and risks under control.

Enabling MDR Compliance and Knowledge Transfer in Medical Software Development

To support MDR alignment, we ensured that all improvements were traceable and documented throughout development. The updated codebase, testing framework, and CI/CD setup were integrated with clear documentation to simplify future audits.

We conducted onboarding sessions with the client’s engineering team, providing training on the new tool chain, testing workflow, and repository structure. This allowed their developers to take ownership of future maintenance and feature development.

By combining technical improvements with process enablement, the client gained both a certifiable software foundation and the in-house capabilities to build on it confidently.

What We Think of the Project Outcome?

The project successfully transformed a complex legacy firmware into a maintainable and certifiable software platform. Key improvements such as modularisation, CI/CD pipelines, and unit testing have reduced technical debt and made future changes safer and faster to implement.

The client now has a codebase that aligns with MDR and IEC 62304 requirements, supports upcoming hardware upgrades, and enables more predictable certification processes. This case highlights how structured medical software development can modernise legacy firmware and prepare companies for future innovation.

By combining technical restructuring with team enablement, the client can continue to build on this foundation independently, ensuring long‑term maintainability and compliance for future generations of their devices.