Regulatory-grade software for medical device manufacturers
For more than a decade we have designed, built, and validated software, simulation, and AI systems for medical devices - ISO 13485 certified for over 8 years. From browser-based SaaS to a CE-marked device, with products acquired by KLS Martin and prototypes built for manufacturers across the industry.
Book a discovery callMedical innovation should not be this slow.
Simulation, AI, and automation have been standard in aerospace and automotive for decades. In medical devices, too much still rides on physical prototypes and manual checks - slow, expensive, and hard to defend in front of a regulator.
We bring proven in-silico methods to the full device lifecycle: from patient data and predictive models to validated software, automated quality layers, and digital manufacturing workflows.
Software development, built for regulated healthcare
An experienced team that has built medical software for over a decade - combining simulation, AI, software engineering, and regulatory know-how under one certified roof.
Biomechanical & FEA simulation
Validated finite-element and biomechanical models that predict how a device behaves under real-world loading - before a physical prototype exists.
Computational Modeling & Simulation
In-silico testing and computational evidence (CM&S) to support EU-MDR and FDA submissions.
AI & machine learning
Predictive models, medical image segmentation, and AI-driven automation of design and quality steps, documented for regulated workflows.
Cloud, Azure & medical SaaS
Scalable, secure cloud applications and multi-tenant SaaS on Microsoft Azure - browser-based, from MVP to certified product.
Digital manufacturing & CAD/CAM
Design-to-production software for milling and 3D printing: automated file validation and repair, geometry processing, and traceability.
Regulatory-aligned engineering & SaMD
EU-MDR, FDA, and the IEC 62304 lifecycle built in - including classification, development, and documentation of Software as a Medical Device (SaMD).
Proof we can build regulated medical software - because we did
Over more than ten years we have taken medical software from research to market. KLS Martin acquired two of our products, but they are one of many: we have also built Simq CAS, AAA, and VIT, run studies for global MedTech leaders like Medtronic, and delivered prototypes for manufacturers across the industry - many under NDA.
From research to a commercial digital-dentistry SaaS
A CE-marked diagnostic device for sleep apnea
Personalizing stock implants at the point of care
Start small, prove it fast, then scale
Start with a proof of concept
Not ready for a full build? We deliver a fast, working PoC so your team can see the product, validate the idea, and sell it internally - before committing to a large investment.
Rapid PoC
A fast prototype that proves the concept and wins internal buy-in.
Specification
Requirements, risk analysis, and an architecture you sign off on.
Development
Iterative build under the IEC 62304 lifecycle.
V&V
Testing and validation, documented for traceability.
Handover
Deployment, documentation, and ongoing support.
Fixed-scope project
A defined deliverable, timeline, and price - ideal for a PoC or bounded module.
Ongoing retainer
A reserved slice of our team to build and maintain software over time.
Embedded team
Our engineers inside your R&D as an extension of it.
Questions buyers ask us
Can we start small before committing?
Yes. Most engagements begin with a rapid proof of concept that lets your team validate the idea and build internal buy-in before a larger investment.
Who owns the code and IP?
You do. The source code, models, and documentation we build for you are yours.
Do you handle regulatory certification?
We develop under ISO 13485 and IEC 62304 and prepare the documentation. We have taken a product through CE marking ourselves (Simq OSA). Whether a product must be filed depends on its classification and intended use.
How fast can you deliver a PoC?
Usually a few weeks, depending on scope - something tangible quickly, not a year before you see anything.
What do engagements look like?
Fixed-scope projects, ongoing retainers, or an embedded team inside your R&D.
Have a medical software, AI, or simulation challenge?
Tell us about the device and where you are stuck. We will tell you honestly whether in-silico engineering can help - and how we would approach it.
Book a discovery call