Meet us at IDS 2027 in Cologne – Book a slot
Meet us at IDS 2027 in Cologne – Book a slot
Evidence before the first physical prototype.
We run simulation as a service for medical device manufacturers: validated in silico testing for approval, virtual implant testing, post-market evidence and patient-specific models. Regulatory-grade, based on ASME V&V 40, delivered by an ISO 13485 certified company.
30-minute call · honest assessment · no strings attached
Trusted by leaders in medical technology and research
Medtronic
Simulation for medical devices
ISO 13485 certified
Active in V&V working groups
Accredited partners at our side
Why simulation
Every prototype iteration costs weeks. Every additional size in a product family multiplies the test effort. And some questions, worst-case anatomies, rare load scenarios, long-term behavior, cannot be answered on a test bench at all.
Simulation closes that gap. Aerospace and automotive have relied on it for decades; regulators now explicitly accept computational evidence, from FDA guidance on computational modeling to in silico methods under EU MDR. What matters is doing it in a way a notified body or the FDA will accept. That is our job.
What we do
In silico testing as objective evidence for your technical documentation. Model credibility and risk management based on ASME V&V 40, aligned with FDA and EU MDR expectations.
Standard-compliant virtual implant testing: strength and function of entire product families, variant and worst-case analyses, screening before you commit to physical tests. Shorter development cycles, less prototype spend.
Finite element and flow models of devices and their interaction with the human body, built and validated by biomechanics engineers who have done this for over a decade.
Models built from real patient data to assess how a device performs in an individual anatomy. The foundation for personalized care and patient-specific devices.
Statistical shape models combined with physics-based simulation: test your design across the anatomical variation of the target population instead of a handful of cadaver geometries. A path toward in silico clinical trials.
Objective performance and safety data for devices already on the market: efficient evidence for PMCF, scientific support for failure analysis and CAPA.
Our test lab partners
Simulation does not replace the test bench, it makes it dramatically more efficient. That is why we work in partnership with two of the most respected accredited testing laboratories for medical devices. Their clients come to us for in silico methods, our clients get accredited physical testing without friction. You get both worlds, coordinated.
Accredited testing laboratory for preclinical mechanical testing of implants, instruments and packaging, based in Rostock. Partner since 2022.
One of the world’s leading ISO 17025 accredited implant testing laboratories, based in Riedering, Bavaria.
Offer your clients validated simulation without building a simulation team. We work as your in silico partner, in the background or side by side.
Proof
SDS Swiss Dental Solutions · FDA approval
The FDA requested proof that further variants of already tested ceramic implants would not exhibit higher loads. Re-testing every variant physically was impossible within the deadline. Our FEA per EN ISO 14801 proved worst-case coverage, and US market approval proceeded without delay.
“SimQ’s FEM analysis allowed us to quickly answer the FDA’s inquiries at a critical approval step for our product and ensure a smooth product launch in the U.S.”
Dr. Karl Ulrich Volz · CEO · SDS Swiss Dental Solutions
Medartis · Post-Market Surveillance
Finite element analyses of different osteosyntheses on the mandible, in cooperation with University Hospital Marburg. Clinical observations from PMCF were reproduced in simulation, resulting in a scientific publication and robust evidence for the technical file.
ulrich medical · Development
Static-mechanical FE analyses proved the safety of titanium screw systems in silico before expensive correction loops could occur. Fewer prototypes, shorter development time, highest quality requirements met.
How we work
A 30-minute call on your device, regulatory context and the question to answer. Honest assessment included.
Question of interest, model scope and validation strategy defined up front, following ASME V&V 40.
We build, run and validate the models, where useful combined with tests at our accredited partner labs.
A traceable simulation report written for your technical documentation, ready for notified body or FDA review.
We stand behind the results: support during audits, submissions and follow-up questions.
FAQ
Usually it reduces it rather than replaces it: fewer prototypes, fewer variants on the bench, worst cases identified up front. Where standards and regulators allow it, in silico results can substitute physical tests entirely. We tell you honestly which case applies to you.
Yes, when model credibility is demonstrated. Our work follows ASME V&V 40 and the relevant FDA guidance on computational modeling, and we are active in the V&V working groups shaping these standards.
Perfectly. We cooperate closely with accredited labs, including INNOPROOF and EndoLab, and are happy to coordinate directly with yours.
No. You bring the device and the question, we bring engineers, software and validated methods. You receive results and reports, not license fees and hiring plans.
You do. Models, data and documentation created in your project belong to you.
Most projects start small: one device, one question, a fixed-scope offer after the scoping call. Ongoing support, for example for PMS or product family extensions, can follow as a retainer.
Tell us in 30 minutes which evidence you need. We will tell you honestly whether simulation is the right way to get it.
Fixed-scope offers · ASME V&V 40 based · ISO 13485 certified
Florian Maier, CMO · meetings.hubspot.com/fmaier
