medular is a reusable embedded software foundation for regulated medical devices. It provides the architecture, the infrastructure services and the verification and documentation record, so the team's work goes into what makes your device yours.
Start with the foundation already built, and put the team on what really matters.
Hardware agnostic by design, so a shortage or an end-of-life notice never becomes a redesign.
Developed from the ground up to IEC 62304 Class C, with a record of everything. No SOUP justification.
THE PROBLEM
In embedded development, only a fraction of the effort goes into what makes the product yours. The rest disappears into building the low-level foundation, debugging it, and writing the documentation the auditor will ask for.
Before a device can do the one thing it exists for, someone has to bring the hardware to life. Getting a display to show an image or a sensor to return a reading you can trust takes a good engineer weeks, sometimes months. It is work no user will ever see, no investor will pay a premium for, and nobody outside the team can read as progress.
Code written directly against a chip only works with that chip. When a part is discontinued, allocated or simply unavailable, the hardware change is small and the software change is not: it must be rewritten, tested and documented again, for a device that already worked.
Time lost at software is never recovered. A week added before a working prototype pushes verification and submission back and every delay raises the risk of never reaching the market.
A team that cannot explain why something failed is the clearest early warning of cost and delay you will get. With no way to ask the device or see what's happening inside, every question means another build, another assembly and disassembly, another day, and an answer that is still a guess.
Software written directly against hardware cannot be proven without it. The team waits for the first boards, no work happens in parallel, and the earliest defects surface on the prototype, months after they could have been found and at many times the cost.
Requirements, design records and test evidence get written after the code, close to submission, for software nobody documented while building it. It is one of the most common sources of audit findings.
SIDE BY SIDE
Plug in medular so your team focuses on the clinical function nobody else can write for you.
REGULATORY
medular is developed within the ISO 13485 quality system, under a software lifecycle that follows IEC 62304 and targets Class C from the first line. Requirements, architecture, detailed design, verification and release records exist for every component and are versioned with the code they describe.
medular is a software component, not a medical device, and carries no CE mark of its own. We deliver the foundation, you build on top of it: the component record comes complete, and the device-level claims, hazard analysis and clinical evidence stay where they belong, with you.
THE LIBRARY
medular sits between your hardware and the part your team writes. It runs the sensors, screens and chips your device already contains, tells you what the device is doing while it runs, and handles what happens when something fails. All of it built to IEC 62304, with the documentation already written. The full catalogue is there. Your device carries only what it uses.
DELIVERY
The engineering core is the same in every option. What changes is how much of it you receive, and what your regulatory submission can claim about it.
The components you select, compiled for the processors your device uses, delivered ready to run. With them, a test suite you execute on your own hardware to confirm what you received behaves as it should.
For non-regulated products, and for teams whose own quality system will carry the regulatory record.
Adds the full Class C package: SRS, SDS, traceability matrix, V&V reports, software FMEA, safety manual with anomaly list, and an SBOM per release.
Enters as developed software, with the record behind it.
Components adapted to your device, new components developed for it, or the complete software built by our team, all executed inside an ISO 13485 quality system with the design records delivered as part of the work.
Engineering by Perdigó Medical, scoped per project.
medular keeps growing: improvements, new versions, bug fixes, and new components in development, with support for new chips as they arrive. The documentation package moves with it, revised for each release and for changes in the applicable standards, including per-release V&V reports, SBOM and anomaly list.
Adds engineering support with agreed response times, and assistance during integration and board bring-up.
Licences are scoped by field of use. A licence sold for non-regulated products cannot be used in a regulated device without an upgrade.
Clients developing a device with Perdigó Medical receive the documentation package as part of the engagement.
Developed by engineers, for engineers: time spent where it counts, on well-written code that stays modular and scales with your product.
WHO WE ARE
medular is the structural member everything else rests on. Hardware drivers, buses, interfaces and error handling are the code every product carries, so build that layer once and each new device starts from a standing structure rather than from zero.
The library is written by embedded engineers at Perdigó Medical, an ISO 13485-certified medical device consultancy in Barcelona. It came out of building regulated software for real devices and rewriting the same drivers for every one of them, until we wrote them once, properly.
CONTACT
Start your next device on a tested, documented foundation, with the runtime tooling and the Class C record already there. Delivery is scoped per project, from a compiled library to full software development. Tell us about the device.
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