In the world of medicine, safety and efficacy are top priorities. That’s why every medical device must undergo rigorous control before entering the market, with clinical trials being a key stage in this process.
**What is it?**Clinical trials (CTs) are scientific studies that confirm a medical device operates safely and performs its intended functions. For devices (unlike drugs), trials often include technical tests on simulators or in real-world conditions, as well as analysis of data from volunteers or patients.
Why are they needed?- Safety confirmation. Trials identify potential risks, side effects, or adverse reactions when using the device.- Proof of efficacy. The device must truly fulfill its purpose: diagnose, treat, or alleviate a condition.- Regulatory compliance. Without positive CT results, it is impossible to obtain a registration certificate from Roszdravnadzor.- Trust from doctors and patients. Trial data is the foundation for specialists to confidently recommend, and patients to use, the device.
Elibrium pays special attention to conducting high-quality clinical trials. Our team supports the entire cycle—from protocol planning to the final report—so your device can reach the market faster and more reliably.
Want to learn more about the CT stages for your product? Contact us—we will consult you on all registration matters!
