Meet us at IDS 2027 in Cologne – Book a slot
Meet us at IDS 2027 in Cologne – Book a slot
For over a decade, we have been developing, validating, and maintaining software, simulation solutions, and AI applications for medical device manufacturers that comply with regulatory requirements. From browser-based SaaS to CE-certified medical devices, with products acquired by KLS Martin.
30-minute call · honest assessment · no strings attached
Trusted by leaders in medical technology and research
Medtronic
Building medical software to IEC 62304
ISO 13485 certified
Software products developed
Products acquired by KLS Martin
Our strength lies in combining digital twins and artificial intelligence: from patient data and predictive models emerge validated, regulatorily robust software solutions.
And we apply AI to our own work: integrated into selected development and quality-assurance steps, it cuts development cost and time while raising quality. AI where it measurably helps, no AI bloat where it does not.
Validated finite element and biomechanics models that predict how a device behaves under real load, before a physical prototype exists.
In silico testing and computational evidence (CM&S) supporting EU MDR and FDA submissions.
AI in your product: predictive models and medical image segmentation. And AI in our process: AI-assisted engineering and quality assurance that reduce cost and time, documented for regulated workflows.
Scalable, secure cloud applications and multi-tenant SaaS on Microsoft Azure, browser-based, from MVP to certified product.
Software from design to production for milling and 3D printing: automated file validation and repair, geometry processing and traceability.
EU MDR, FDA and the IEC 62304 lifecycle considered from day one, including classification and documentation of Software as a Medical Device.
In more than ten years we have taken medical software from research to market. Two of our products were acquired by KLS Martin. Three examples:
Two cloud products: one-click strength simulation and automated CAD/CAM file validation with repair, backed by a validated database of more than 400 materials. Built to ISO 13485 and IEC 62304, in daily use at labs and milling centers across Europe and North America.
A product that builds a patient-specific model of the upper airway and makes flow simulation usable for diagnostics. Developed and CE-certified by us, acquired by KLS Martin in an asset deal.
Simulation-based strength verification for patient-specific implants, integrated into the manufacturer’s design workflow. Also acquired by KLS Martin and in use there today.
We have also built Simq CAS, AAA and OSP, run studies for global medtech companies such as Medtronic, and delivered prototypes for manufacturers across the industry, many under NDA.
From flow simulation to surgical planning: four of our flagship products, representative of many more applications from over ten years of development. All share the same architecture, the same report workflow and the same ISO 13485 quality foundation.
You bring the idea, we bring a complete development team. Simq builds custom software end to end, from first concept to running product, with the discipline of an ISO 13485 certified company behind every line of code. No hiring, no overhead, no half-finished projects.
Beyond software development, we support manufacturers with simulation services along the entire product lifecycle:
Not ready for a full build? We deliver a working PoC within a few weeks, something tangible your team can evaluate and present internally, before committing to a large investment.
A fast prototype that proves the concept and wins internal buy-in.
Requirements, risk analysis, and an architecture you sign off on.
Iterative build under the IEC 62304 lifecycle.
Testing and validation, documented for traceability.
Deployment, documentation, and ongoing support.
A defined deliverable, timeline, and price, ideal for a PoC or bounded module.
A reserved slice of our team to build and maintain software over time.
Our engineers inside your R&D as an extension of it.
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.
You do. The source code, models, and documentation we build for you are yours.
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.
Usually a few weeks, depending on scope. Something tangible quickly, not a year before you see anything.
A fixed-scope project, an ongoing retainer, or an embedded team inside your R&D, whichever fits. The intellectual property always stays with you.
In selected development and quality-assurance steps where it measurably saves time: code generation under review, documentation, test automation, image and data processing. Every result goes through our ISO 13485 process. AI where it helps, no AI bloat where it does not.
From idea to working prototype. Fast. Rapid PoC in weeks · Your IP, always · ISO 13485 certified
