Innovation as a driver
At Ellios Bio Tek, the quality of our products is a fundamental pillar of our approach. By placing great importance on selecting premium materials, we ensure not only the durability and safety of our medical devices but also pay close attention to their ergonomics. This focus on ergonomic design enables practitioners to handle them with ease while providing optimal comfort for patients.
We have established an ongoing collaborative relationship with our users. This proactive approach allows us to gather valuable feedback, which plays a crucial role in the continuous improvement of our existing devices. By listening to practitioners, we are able to quickly identify areas that require adjustments or enhancements.
This two-way communication goes beyond adapting existing products; it also paves the way for the design of new, innovative devices tailored to evolving medical practices and patient needs.
Safety and regulatory standards
At Ellios Bio Tek, the safety and regulatory compliance of our medical devices are at the heart of our priorities. The sterilization of our products is tailored to their nature and to the specific regulatory requirements of each country. Two methods are used:
Gamma irradiation, recognized for its high effectiveness on heat-sensitive materials,
Ethylene oxide (EtO), used when material compatibility requires it.
Quality control is systematically applied to each batch of products intended for Assisted Reproductive Technology (ART), an area where risk tolerance is zero.
Two tests are conducted:
LAL (Limulus Amebocyte Lysate): This test detects the presence of bacterial endotoxins, which can be potentially harmful to reproductive cells or embryos.
MEA (Mouse Embryo Assay): It evaluates the potential embryotoxicity of the product by observing the development of mouse embryos in contact with the device.
These tests ensure maximum safety for patients and healthcare professionals, while complying with the strictest standards in the manufacturing of medical devices dedicated to human reproduction.