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In-silico testing — using computational modeling and simulation techniques — has rapidly become an important method for supporting compliance with the EU Medical Device Regulation (MDR).
It is especially valuable during early design stages, where it can (re)direct device development before physical testing. Regulatory bodies increasingly recognize in silico testing as valid supporting evidence—alongside traditional pre-clinical and clinical studies.
In this blog post, we explain what in-silico testing is, how it supports MDR documentation, and how to integrate it into your technical file.
What is in-silico testing?
In-silico testing involves using computer simulations to evaluate medical devices in virtual environments. It can be used to predict performance, durability, safety, and even biological interactions without the need for immediate bench, animal, or human testing.
The ultimate goal? To complement or even reduce the extent of animal and clinical studies, while enhancing the robustness of device evaluations.
Supporting Clinical Evaluation Reports (CERs) and performance evaluations
In-silico testing can strengthen Clinical Evaluation Reports (CERs) and performance evaluations by:
These simulations help bridge the gap between bench data and real-world performance, especially for innovative or high-risk devices.
Example scenarios for Class II and Class III Devices
How to successfully integrate in-silico testing into MDR compliance
To make in-silico testing count as valid evidence under MDR, manufacturers should:
Regulators want traceability, transparency, and technical justification—especially for high-risk or novel devices.
Conclusion: a strategic move toward MDR compliance
In-silico testing under MDR is not just an option—it’s a smart strategic choice. It enables design decisions, faster iterations, earlier risk detection, and stronger technical files. As regulatory expectations evolve, embracing in silico testing puts you ahead of the compliance curve—while also improving patient safety and reducing reliance on traditional testing methods.
How QbD Group can support you
At QbD Group, we help medical device manufacturers integrate in-silico testing into their MDR compliance strategy. Our experts can:
Want to explore how in silico testing can support your device strategy? Let’s talk about how we can help.
Contact us for expert guidance.
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