Medical Device Firmware — Cost Guide
What Does Medical Device Firmware Development Cost?
Medical device firmware development typically costs $50K–$250K+ from architecture through verification. The price is driven less by lines of code than by device class and evidence burden: IEC 62304 software class, IEC 60601-1 safety and EMC requirements, ISO 14971 risk work, and the V&V documentation a submission requires. The cheapest way to control the number is a short fixed-price architecture diagnostic before you commit to a build.
How to choose
What to look for
Software safety class (IEC 62304 A/B/C)
Class C fault handling, safe states, and testing depth can double the effort versus Class A. Classify honestly before anyone quotes you.
Evidence burden, not just code
DHF documentation, traceability, risk files, and V&V protocols routinely cost as much as the implementation for Class B/C devices — and they are what the FDA reviews.
Connectivity and cybersecurity scope
BLE or Wi-Fi telemetry adds stack integration, testing, and FDA cybersecurity documentation. Connected devices sit at the upper end of the range.
Hardware maturity
Firmware quoted against an unstable board absorbs the board’s problems. Stabilizing the electronics first keeps the firmware spend predictable.
How Kyros compares
| Criterion | Kyros Engineering | Typical low-bid approach |
|---|---|---|
| Estimate basis | Fixed price per milestone after a $6K architecture diagnostic | Hourly rate × optimistic guess |
| What’s included | Firmware plus risk files, traceability, and V&V evidence | Code only; documentation extra or absent |
| Change orders | Scoped milestones absorb normal iteration | Every discovery is a change order |
| Regulatory rework risk | Compliance designed in from architecture | Retrofit before submission — the expensive path |
| Total cost of ownership | Predictable; evidence ready for submission | Low day-rate, high total after rework |
Frequently asked
How much does firmware cost for a Class II medical device?
Commonly $75K–$250K from architecture through verification, depending on IEC 62304 software class, connectivity, and V&V depth. Simple accessories or instrument updates can land lower; safety-critical or connected devices trend higher.
Why does medical firmware cost more than consumer firmware?
The code is often comparable — the evidence is not. Design controls, ISO 14971 risk analysis, traceability, and verification protocols are deliverables in their own right, and they are what the FDA reviews.
What is the cheapest way to de-risk the budget?
A short fixed-price architecture diagnostic — Kyros runs these at $6K over two weeks. You get a written architecture, risk, and cost plan you keep, whoever you hire for the build.
Should medical firmware be fixed price or time-and-materials?
Kyros quotes firm-fixed-price tied to milestones for defined scope; T&M is reserved for genuine unknown-unknown R&D phases. Buyers in regulated industries increasingly require fixed-price milestones.
Get a real number for your device
Tell us the device, class, and timeline. A principal engineer will give you a straight read on scope and cost — including whether you need less than you think.
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