Medical device software development, under your quality system.
We are the senior engineers who build your medical device software to IEC 62304 and IEC 62366-1, inside your ISO 13485 quality system. We produce the software evidence your quality and regulatory people need.
A senior software team that has shipped regulated, connected products. Plain answers first.
The standards evidence, mapped to what we produce and what stays yours.
A firm that welcomes your qualification and audit.
Standards are evidence, not badges. We produce the software evidence your quality and regulatory people need.
A standard is not a badge you hang on a wall. It is the evidence a reviewer, an auditor or a notified body asks to see. So we do not sell you a certification. We build your software the way the standard requires, and we hand your quality and regulatory people the records, the traceability and the test evidence they need to do their job.
You keep the quality system. We work inside it, and we leave a clean evidence trail behind us. That is the whole job, and it is a rarer thing than it sounds.
What we do, exactly. And the line we hold.
We build medical device software to IEC 62304 and IEC 62366-1. We work under your ISO 13485 quality system. Our software risk analysis feeds your ISO 14971 risk file. For medical devices, that work is built to withstand the scrutiny FDA and EU MDR bring.
We built the software for ResMed's first consumer product, and for the world-first sonar sleep tracking that shipped in SleepScore and reached market.
We built the original Bluetooth SDK for Fire1's implantable cardiac device, now in clinical trials.
We are the software engineering team inside your process. We are not a notified body, a certification body or a regulatory adviser, and we say so plainly.
What we do, the evidence we produce, and what stays yours.
Four standards run this work. On two we produce the evidence outright. On two we contribute the software inputs, and the file itself stays yours. We do not level any of them up.
Build the software to a risk-based, versioned, traceable lifecycle.
Design records, requirements traceability, verification and test evidence, release records.
Release authority, and the quality system itself.
Usability engineering, user research and UX design, done by our own design team before the build.
Use-specification inputs, use-related risk inputs, and the design evidence that feeds your usability engineering file.
The usability engineering file itself, and the formal usability evaluation.
Work to your controlled processes, and your regulatory partner's.
Controlled documents, and inputs to your design history file or your EU technical documentation.
The quality system itself, and the regulatory process.
Software risk analysis that feeds your risk file.
Hazard and mitigation records, software-level risk inputs.
The ISO 14971 risk management file itself.
Since February 2026, the FDA's Quality Management System Regulation incorporates ISO 13485:2016 by reference. So working inside your ISO 13485 system now speaks to the US framework as well as the EU. It does not make ISO 13485 equal to FDA compliance. The QMSR keeps FDA-specific requirements on top.
Senior engineers, inside your process, in your time zone.
Our own design team does the usability engineering, the user research and the UX before the build. The generalist shops in this lane do not have design in the same building, working to the usability standard. That is where IEC 62366-1 is won or lost.
Where a build needs specialist regulated expertise, device cybersecurity for one, we bring it in and manage it inside the same lifecycle. No hand-off, no gap in the evidence. We cover the SBOM and the secure-development inputs a vendor-risk reviewer checks first.
Senior EU-based engineers. English-speaking, and in your time-zone overlap. We overlap your US working morning. Ireland and the EU is a trust and regulatory-proximity signal, close to the standards and regulators your product answers to. It is not a cost pitch, and we never sell it as one.
Built where getting it wrong is expensive.
The work is only as good as the eye behind it. Fourteen years of builds where the margin for error is zero, and more than forty codebases opened and assessed since 2012. That is the eye we bring to yours.
We built the software for ResMed's first consumer product, and for the world-first sonar sleep tracking that shipped in SleepScore and reached market.
The sonar science is ResMed's. We built the software.
We built the original Bluetooth Low Energy SDK for Fire1's implantable cardiac device, now in clinical trials.
Connected-device engineering where the margin for error is zero.
Fourteen years of BLE, firmware and SDK work on connected products. That is the device depth the generalist shops in this lane do not have.
Biometric identity work at national scale, for Safran Morpho and Idemia. National institutions as direct clients. The eye that has opened forty codebases reads yours the same way.
Straight answers, for the reader who scans for gaps.
Yes. We work to your controlled processes, and your regulatory partner's. We produce controlled documents and inputs to your design history file, or your EU technical documentation. You keep the quality system. We work inside it.
You do. The ISO 13485 quality system, the ISO 14971 risk management file and the IEC 62366-1 usability engineering file are yours, and they stay in your system. We produce and contribute the software engineering evidence that feeds them.
The IEC 62304 artefacts: design records, requirements traceability, verification and test evidence, and release records. Written to fit your lifecycle, not ours.
No. We produce the software engineering inputs and evidence that feed their work. We are not a notified body, a certification body or a regulatory adviser.
Yes. We expect it, and we will answer your vendor-risk and security questions directly, under your process. References are available on request.
Maintenance, change control under your process, and problem resolution. Software changes stay traceable and version-controlled, so your evidence keeps up with the product.
We do not do device cybersecurity in-house. Where a build needs it, we bring in specialist expertise and manage it inside the same lifecycle, so the security evidence lands with everything else. No hand-off, no gap.
Both. For the US, we work inside your ISO 13485 and QMSR-aligned system and produce the premarket software documentation. For the EU, we produce the software documentation for MDR and notified-body review. You make the submission. We produce the evidence behind it.
A short technical fit call first, then a scoped engagement. We build to the standard from day one. Where you have no quality system yet, we produce evidence that will slot into one as it forms, and we tell you plainly when to bring in RA or QA.
Talk to an engineer.
It starts with a short technical fit call. Your stage, the software scope, how we interface with your quality system, the evidence you will need, and the next step. A senior engineer, not a sales layer.
We answer the vendor-risk questions directly: how we interface with your QMS, our security posture, insurance, continuity, and references.
53.7°N -7.8°W · IRELAND
EST. 2012 · EU
hello@purpledecks.com
Best fit is a funded medtech team that needs senior software delivery inside an existing or emerging quality system. If you need a certified partner to own the quality system outright, the certified specialists serve that need, and we will tell you so.