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Revolutionizing Blood Purification: hemotune Attains ISO 13485 Certification

We are thrilled to announce a significant milestone in our journey to revolutionize blood purification and transform patient care. hemotune AG has achieved ISO 13485 certification, a globally recognized standard for medical device quality management systems. This achievement underscores our commitment to delivering safe and effective medical devices based on cutting-edge nanotechnology.

The scope of our ISO 13485 certification encompasses design and development, production, distribution, and service of medical devices for blood purification, including our groundbreaking coated colloidal nanoparticles. This certification is a testament to our dedication to rigorous quality standards and regulatory compliance, ensuring that our practices consistently meet customer and regulatory requirements throughout the lifecycle of our innovative medical solutions.

At hemotune, we have always strived for excellence in our pursuit of creating a better future for patients. This certification not only reflects our unwavering commitment but also positions us to confidently deliver nanoparticle-based medical products that adhere to the highest standards.

We are proud to have achieved this milestone and are grateful to our dedicated team, partners, and supporters who have contributed to our success. With ISO 13485 certification in hand, we are well-equipped to continue advancing our mission of transforming patient outcomes through innovative medical solutions.

Stay tuned as we embark on the next phase of our journey, bringing the potential of nanotechnology to the forefront of medical innovation.

Read the full press release here:

230821 Press Release_ISO13485_GER
PDF herunterladen • 182KB

230821 Press Release_ISO13485_ENG
PDF herunterladen • 173KB


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