At hemotune, our quality policy is rooted in our vision, mission, and values. We are committed to patient safety, product quality, and compliance with all applicable laws, regulations, and standards. Guided by integrity and excellence, we work as one team across all levels, with every employee actively contributing to our shared quality goals—because improving patient outcomes depends on it.

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EN ISO 13485:2016

The EN ISO 13485 certification covers design and development, production, distribution, and service of sterile and non-sterile medical devices for blood purification including sterile and non-sterile coated colloidal nanoparticles and marks a significant milestone towards delivering our innovative blood purification technology to patients.