Built by engineers who've shipped regulated software.
Not consultants who've only reviewed it. We've built SaMD products, navigated FDA submissions firsthand, and contributed to the standards we help you implement.
We started ReguSoft because we saw too many device manufacturers struggling with cybersecurity requirements that were explained in regulatory language instead of engineering language. Our approach is different: clear documentation, honest assessments, and fixed-price delivery.
Experience that matters
We write documentation in engineering language, not regulatory jargon. Your team should be able to read our deliverables and understand exactly what they mean for your product architecture and development process.
We don't just implement standards — we contribute to developing them. Our participation in IEC standards committees means we understand not just the letter of the requirements, but the intent behind them.
How we work
Honest assessments
We tell you what you actually need, not what generates the most billable hours. If you're already compliant in an area, we'll say so.
Fixed-price delivery
We scope upfront and deliver at a fixed price. No surprises, no scope creep. If we underestimate, that's our problem.
Clear documentation
Our deliverables are structured, readable, and written for engineers. Not 200-page PDFs that nobody reads.
Let's talk about your device.
No sales pitch — just a straightforward assessment of what you need and what it will cost.